Heart Failure With Left Bundle Branch Block Clinical Trial
Official title:
AdaptResponse Clinical Trial
| Verified date | November 2023 |
| Source | Medtronic Cardiac Rhythm and Heart Failure |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
| Status | Completed |
| Enrollment | 3797 |
| Est. completion date | November 2, 2022 |
| Est. primary completion date | November 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Subject is willing to sign and date the study Patient Informed Consent Form. - Subject is indicated for a CRT device according to local guidelines. - Sinus Rhythm at time of enrollment - Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior to enrollment). Strauss Criteria used for LBBB. - Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms (within 30 days prior to enrollment). - Left ventricular ejection fraction less than or equal to 35% (documented within 180 days prior to enrollment). - NYHA class II, III or IV (documented within 30 days prior to enrollment) despite optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist. Exclusion Criteria: - Subject is less than 18 years of age (or has not reached minimum age per local law). - Subject is not expected to remain available for at least 2 years of follow-up visits. - Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted - Subject is, or previously has been, receiving cardiac resynchronization therapy. - Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. - Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 30 days prior to enrollment. - Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. - Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded). - Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. - Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to device implant). - Subject meets any exclusion criteria required by local law. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Austin Hospital | Heidelberg | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | John Hunter Hospital | New Lambton | New South Wales |
| Australia | Saint Vincent's Hospital (Sydney) | Sydney | |
| Austria | Landeskrankenhaus Innsbruck - Universitätskliniken | Innsbruck | |
| Austria | Allgemeines Krankenhaus der Stadt Linz | Linz | |
| Belgium | AZ Sint-Jan Brugge-Oostende av | Brugge | |
| Belgium | Ziekenhuis Oost Limburg - Campus St.-Jan | Genk | |
| Canada | London Health Sciences Centre - University Campus | London | |
| Canada | McGill Universtiy Health Centre (MUHC) | Montreal | |
| Canada | Southlake Regional Health Centre | Newmarket | |
| Canada | University of Ottawa Heart Institute | Ottawa | |
| Canada | Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) | Quebec | |
| Canada | Royal Columbian Hospital | Vancouver | |
| Canada | Vancouver General Hospital | Vancouver | |
| Denmark | Odense Universitetshospital | Odense C | |
| Finland | Keski-Suomen Keskussairaala | Jyväskylä | |
| Finland | Satakunnan keskussairaala | Pori | |
| France | Centre Hospitalier Universitaire de Amiens - Hôpital SU | Amiens | |
| France | CHRU Tours - Hôpital Trousseau | Chambray lès tours | |
| France | Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | |
| France | Centre Hospitalier Sud Francilien | Corbeil-Essonnes | |
| France | CHRU La Rochelle | La Rochelle | |
| France | Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon | La Tronche | |
| France | CHRU de Lille | Lille | |
| France | groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert | Lomme | |
| France | Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille | Marseille | |
| France | Hopital prive Clairval - Ramsay Sante | Marseille | |
| France | Institut Hospitalier Jacques Cartier | Massy | |
| France | CHR Metz-Thionville Hôpital de Mercy | Metz | |
| France | CHRU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier Cedex 5 | |
| France | Nouvelles Cliniques Nantaises | Nantes | |
| France | CMC-Clinique Ambroise Pare | Neuilly-sur-Seine | |
| France | Hôpital Pontchaillou - CHU de Rennes | Rennes Cedex 9 | |
| France | CHU Toulouse - Hôpital Rangueil | Toulouse Cedex 9 | |
| Germany | Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg | Bernau bei Berlin | |
| Germany | Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum | Bochum | |
| Germany | MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz | Chemnitz | |
| Germany | Klinikum Coburg GmbH | Coburg | |
| Germany | Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden | Dresden | |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Universitätskliniken des Saarlandes | Homburg/Saar | |
| Germany | Universitätsklinikum Jena - Friedrich Schiller Universität | Jena | |
| Germany | Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck | |
| Germany | Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH | Lüdenscheid | |
| Germany | Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid | Lüdenscheid | |
| Germany | Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R. | Magdeburg | |
| Germany | Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus | Mönchengladbach | |
| Germany | Klinikum der Universität München - Campus Großhadern | München | |
| Germany | Herz Riesa, Gemeinschaftspraxis | Riesa | |
| Germany | Universitätsklinikum Ulm | Ulm | |
| Hungary | Magyar Honvédség Honvédkorház | Budapest | |
| Hungary | Semmelweis Egyetem AOK | Budapest | |
| India | Medanta - The Medicity | Gurgaon | |
| India | Fortis Escorts Heart Institute | New Delhi | |
| Italy | Policlinico Sant' Orsola - Malpighi | Bologna | |
| Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
| Italy | Ospedale Civile Madonna Della Navicella | Chioggia | |
| Italy | Azienda Ospedaliera Carlo Poma | Mantova | |
| Italy | Azienda Ospedaliero-Universitaria di Parma | Parma | |
| Italy | Azienda Ospedaliera Universitaria Integrata Verona | Verona | |
| Japan | Chiba University Hospital | Chiba-Shi | |
| Japan | Hirosaki University Hospital | Hirosaki | Aomori Prefecture |
| Japan | Kokura Memorial Hospital | Kitakyushu | |
| Japan | Kyorin University Hospital | Mitaka-Shi | |
| Japan | Nagoya University Hospital | Nagoya | |
| Japan | Sakakibara Heart Institute of Okayama | Okayama-Shi | |
| Japan | Saitama Medical Center Jichi Medical University | Shimonoseki-Shi | |
| Japan | National Cerebral and Cardiovascular Center | Suita-Shi | |
| Japan | Fujita Health University Hospital | Toyoake | |
| Japan | University of Fukui Hospital | Tsukuba | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center | Daegu | |
| Korea, Republic of | Seoul National University Bundang Hospital | Gyeonggi-Do | |
| Korea, Republic of | Kyung Hee University Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Mexico | Hospital Angeles Leon | Leon | Guanajuato |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Amphia Ziekenhuis - Locatie Molengracht Breda | Breda | |
| Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
| Netherlands | Canisius-Wilhelmina ziekenhuis | Nijmegen | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | |
| Netherlands | Maasstad Ziekenhuis | Rotterdam | |
| Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
| Netherlands | Isala Klinieken - Locatie Weezenlanden | Zwolle | |
| Norway | Helse Bergen HF - Haukeland Universitetssjukehus | Bergen | |
| Poland | Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu | Kalisz | |
| Poland | Górnoslaskie Centrum Medyczne im prof Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | |
| Poland | Regional Hospital Szpital Wojewodski | Kielce | |
| Poland | Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego | Lublin | |
| Poland | Spital Wojewodzki nr 2 | Rzeszów | |
| Poland | Slaskie Centrum Chorob Serca | Zabrze | |
| Portugal | Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes | Beja | |
| Portugal | Centro Hospitalar de Coimbra | Coimbra | |
| Portugal | Hospital de Espírito Santo E.P.E. | Évora | |
| Puerto Rico | The Arrhythmia Group | Coto Laurel | |
| Puerto Rico | Cardiovascular Center | San Juan | |
| Russian Federation | AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation | Moscow | |
| Russian Federation | EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation | Novosibirsk | |
| Russian Federation | Almazov National Medical Research Centre | St Petersburg | |
| Saudi Arabia | King Abdul Aziz University Hospital | Jeddah | |
| Saudi Arabia | King Fahad Armed Forces Hospital | Jeddah | |
| Saudi Arabia | King Faisal Specialist Hospital & Research Center | Riyadh | |
| Saudi Arabia | The College of Medicine & King Khalid University Hospital, King Saud University | Riyadh | |
| Slovakia | Stredoslovensky ustav srdcovych a cievnych chorob a.s | Banska Bystrica | |
| Slovakia | NUSCH, a.s. | Bratislava 37 | |
| Spain | Hospital Universitario Infanta Cristina | Badajoz | |
| Spain | Nuevo Hospital de Burgos | Burgos | |
| Spain | Hospital Virgen de la Arrixaca | El Palmar | |
| Spain | Hospital Universitario Virgen de las Nieves | Granada | |
| Spain | Hospital Clínico Virgen de la Victoria | Málaga | |
| Spain | Hospital Clinico Universitario de Salamanca | Salamanca | |
| Spain | Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes | Vigo | |
| Spain | Hospital Universitario Miguel Servet | Zaragoza | |
| Sweden | Karolinska Universitetssjukhuset | Solna | |
| Sweden | Akademiska Sjukhuset | Uppsala | |
| Switzerland | Universitätsspital Basel | Basel | |
| Switzerland | HFR Fribourg - Hôpital cantonal | Fribourg | |
| Switzerland | Kantonsspital St.Gallen | Saint Gallen | |
| Taiwan | National Taiwan University Hospital Hsin Chu Branch | Hsinchu | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| United Kingdom | Golden Jubilee National Hospital - NHS Trust | Glasgow | |
| United Kingdom | Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | |
| United Kingdom | University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital | Liverpool | |
| United Kingdom | Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital | London | |
| United Kingdom | Manchester University NHS Foundation Trust - Wythenshawe Hospital | Manchester | |
| United States | Presbyterian Heart Group | Albuquerque | New Mexico |
| United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Asheville Cardiology Associate PA | Asheville | North Carolina |
| United States | Emory University Hospital Midtown | Atlanta | Georgia |
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | Texas Cardiac Arrhythmia Research | Austin | Texas |
| United States | MedStar Health Research Institute | Baltimore | Maryland |
| United States | Massachusetts General Hospital (Boston MA) | Boston | Massachusetts |
| United States | Bridgeport Hospital | Bridgeport | Connecticut |
| United States | New York Methodist Hospital | Brooklyn | New York |
| United States | The University of Vermont Medical Center Inc | Burlington | Vermont |
| United States | Capital Area Research | Camp Hill | Pennsylvania |
| United States | CAMC Health Education & Research Institute Inc | Charleston | West Virginia |
| United States | Medical University of South Carolina (MUSC) | Charleston | South Carolina |
| United States | University of Virginia Medical Center | Charlottesville | Virginia |
| United States | Northwerstern University | Chicago | Illinois |
| United States | Bethesda North Hospital | Cincinnati | Ohio |
| United States | The Lindner Research Center | Cincinnati | Ohio |
| United States | Heart & Vascular Institute of Florida | Clearwater | Florida |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | Penrose Hospital | Colorado Springs | Colorado |
| United States | Mount Carmel East | Columbus | Ohio |
| United States | OhioHealth Research Institute | Columbus | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| United States | The University of Texas (UT) Southwestern Medical Center | Dallas | Texas |
| United States | Duke University Medical Center (DUMC) | Durham | North Carolina |
| United States | North Ohio Heart-Elyria | Elyria | Ohio |
| United States | Sacred Heart Medical Center | Eugene | Oregon |
| United States | Florida Heart Rhythm Specialists PLLC | Fort Lauderdale | Florida |
| United States | The Cardiac & Vascular Institute | Gainesville | Florida |
| United States | Wake Forest Baptist Health High Point Medical Center | High Point | North Carolina |
| United States | CHI St. Luke's Heath Baylor College of Medicine Medical Center | Houston | Texas |
| United States | Saint Francis Medical Group Indiana Heart Physician | Indianapolis | Indiana |
| United States | First Coast Cardiovascular Institute PA | Jacksonville | Florida |
| United States | Glacier View Research Institute Cardiology | Kalispell | Montana |
| United States | Mid America Heart Institute (MAHI) | Kansas City | Missouri |
| United States | Scripps Green Hospital Scripps Clinic Torrey Pines | La Jolla | California |
| United States | Lancaster General Hospital | Lancaster | Pennsylvania |
| United States | Sparrow Clinical Research Institute | Lansing | Michigan |
| United States | Saint Vincent Heart Clinic Arkansas | Little Rock | Arkansas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Medical Center of the Rockies | Loveland | Colorado |
| United States | Sutherland Cardiology Clinic | Memphis | Tennessee |
| United States | CardioVascular Associates of Mesa | Mesa | Arizona |
| United States | Cardiovascular Research Center of South Florida | Miami | Florida |
| United States | Aurora Cardiovascular Services | Milwaukee | Wisconsin |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota |
| United States | Centennial Heart Cardiovascular Consultants LLC | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Ochsner Medical Center | New Orleans | Louisiana |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | NYU Langone Medical Center | New York | New York |
| United States | Weill Medical College of Cornell University | New York | New York |
| United States | Mercer Bucks Cardiology | Newtown | Pennsylvania |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma |
| United States | AdventHealth Cardiovascular Research Institute | Orlando | Florida |
| United States | Cardiology Institute of Northwest Florida | Panama City | Florida |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Phoenix Cardiovascular Research Group, LLC | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania |
| United States | Baylor Research Institute | Plano | Texas |
| United States | Hudson Valley Heart Center | Poughkeepsie | New York |
| United States | Raleigh Cardiology Associates | Raleigh | North Carolina |
| United States | Virginia Cardiovascular Specialists PC | Richmond | Virginia |
| United States | Virginia Commonwealth University Health System | Richmond | Virginia |
| United States | North Memorial Heart and Vascular Institute | Robbinsdale | Minnesota |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | United Heart and Vascular Clinic | Saint Paul | Minnesota |
| United States | University of Utah | Salt Lake City | Utah |
| United States | Coggins & Levy Medical Associates | San Jose | California |
| United States | Great Valley Cardiology | Scranton | Pennsylvania |
| United States | Swedish Medical Center Cherry Hill | Seattle | Washington |
| United States | Providence Spokane Cardiology | Spokane | Washington |
| United States | Prairie Education and Research Cooperative | Springfield | Illinois |
| United States | Stanford Hospital & Clinics | Stanford | California |
| United States | Saint Joseph's Medical Center | Stockton | California |
| United States | Stony Brook University Medical Center | Stony Brook | New York |
| United States | University of South Florida Health (USF) | Tampa | Florida |
| United States | EP Heart LLC | The Woodlands | Texas |
| United States | William Beaumont Hospital | Troy | Michigan |
| United States | Tyler Cardiovascular Consultants | Tyler | Texas |
| United States | Central New York Cardiology | Utica | New York |
| United States | Lourdes Cardiology Services | Voorhees | New Jersey |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | Michigan Heart | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure |
United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation | The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization). | from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | |
| Secondary | All-cause Mortality | All-cause mortality in the aCRT ON group vs the aCRT OFF group | from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years) | |
| Secondary | Percent of Patients With Interventions for Heart Failure Decompensation | First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization. | from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years) | |
| Secondary | Clinical Composite Score | The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened NYHA class (using last observation carried forward), or worsened status on the Global Assessment Score. Also patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged. | CCS at 6 month post randomization | |
| Secondary | Atrial Fibrillation | Occurrence of atrial fibrillation lasting >6 hours in one day | from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years) | |
| Secondary | Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL | from baseline to 24M follow up | |
| Secondary | Change in Quality of Life Measured by the EQ-5D | The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health. | from baseline to 24M follow up | |
| Secondary | All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years | All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years | from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years) |