MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

Heart Failure Clinical Trial

— MORE CRT MPP  

Official title:

MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02006069
• Other study ID #: CR-13-006-ID-HF
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Description:

This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5850
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)

• Must be willing and able to comply with study requirements

• Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

• Already had a CRT device implanted

• Myocardial Infarction, unstable angina within 40 days prior the enrollment

• Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following

• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment

• Primary valvular disease

• Atrial Fibrillation:

• Persistent AF at the time of enrollment

• Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant

• History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment

• Unable to comply with the follow up schedule

• Less than 18 years of age

• Pregnant or are planning to become pregnant during the duration of the investigation

• Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months

• Undergone a cardiac transplantation

• Life expectancy < 12 months

• Currently participating in any other clinical investigation

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• MPP
All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Flinders Medical Centre	Bedford Park
Australia	St. Andrews War Memorial Hospital	Brisbane
Australia	The Alfred Hospital	Melbourne
Australia	Westmead Hospital	Westmead
Austria	Krankenhaus der Stadt St. Poelten	St. Poelten
Austria	Krankenhaus Hietzing	Vienna
Austria	Wilhelminenspital	Vienna
Belgium	Hopital Erasme	Brussels
Belgium	St. Joseph Gilly	Gilly
Canada	Foothills Medical Centre	Calgary
Canada	Royal Alexandra Hospital	Edmonton
Canada	QEII Health Sciences	Halifax
Canada	Kingston General Hospital	Kingston
Canada	Institut de Cardiologie de Montreal	Montreal
Canada	Hôtel Dieu de CHUM	Montréal
Canada	McGill University Health Centre General Hospital	Montréal
Canada	Institut de Cardiologie de Quebec	Sainte-Foy
Canada	CHUS Fleurimont	Sherbrooke
Canada	HSC, Eastern Health	St. Johns
Canada	Rouge Valley Centenary	Toronto
Canada	St. Paul's Hospital	Vancouver
China	Prince of Wales Hospital	Hong Kong
Colombia	Angiografia Clinica de Occidente	Cali
Colombia	Clínica Cardio VID	Medellín
Denmark	Aalborg Sygehus Syd	Aalborg	Nordjylland
Denmark	Skejby University Hospital	Aarhus
Denmark	Odense University Hospital	Odense	Fyn
Finland	Keski-Suomi Central Hospital	Jyvaskyla
Finland	Turku University Hospital	Turku
France	CHU Cavale Blanche	Brest
France	CHU Trousseau	Chambray-lès-Tours
France	CHU François Mitterrand Dijon Bourgogne	Dijon
France	CHRU Albert Michallon	Grenoble
France	CHRU Lille	Lille
France	Hopital Saint Philibert	Lomme
France	Hôpital Clairval	Marseille	Alpes
France	Hôpital Saint Joseph	Marseille
France	Centre Hospitalier de Belfort-Montbeliard	Montbéliard
France	CHU Montpellier	Montpellier
France	CHU de Nancy - Hopital de Brabois	Nancy
France	CHU Hopital G. & R. Laënnec	Nantes
France	Nouvelles cliniques Nantaises	Nantes
France	Centre Cardiologique Du Nord	Paris
France	Hopital Pitiè Salpetrière	Paris
France	Institute Cardio. Paris-Sud - Institut Jacques Cartier	Paris
France	CHRU Hôpital de Pontchaillou	Rennes
France	CHRU Rouen Hospital Charles Nicolle	Rouen
France	CHR de La Reunion - Site du CHFG	Saint-Denis Cedex
France	Centre Hospitalier de Valence	Valence
France	Clinique du Tonkin	Villeurbanne
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen	Baden-Württemberg
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim	Hessen
Germany	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen
Germany	Schuchtermann-Schillersche Kliniken	Bad Rothenfelde
Germany	Charite Campus Virchow Klinikum	Berlin
Germany	Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin
Germany	Klinikum Bielefeld	Bielefeld
Germany	Berufsgenossenschaftliche Kliniken Bergmannsheil	Bochum
Germany	Klinikum Coburg	Coburg
Germany	Helios-Klinikum Erfurt GmbH	Erfurt
Germany	Kliniken der Friedrich-Alexander-Universität	Erlangen
Germany	Elisabeth-Krankenhaus Essen GmbH	Essen
Germany	Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem	Göttingen	Niedersachsen
Germany	Universitätsmedizin Göttingen Georg-August-Universität	Göttingen
Germany	Universitatsklinikum Greifswald	Greifswald
Germany	Klinikum Gütersloh gGmbH	Gütersloh
Germany	Albertinen-Krankenhaus Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Klinikum Ingolstadt	Ingolstadt
Germany	Evangelisches Krankenhaus Kalk gGmbH	Köln	Nordrhein-Westfalen
Germany	Medizinische Einrichtungen der Universität zu Köln	Köln	Nordrhein-Westfalen
Germany	St. Vinzenz-Hospital	Köln
Germany	Klinikum St. Georg gGMbH	Leipzig
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum Ludenscheid	Ludenscheid
Germany	St.-Marien-Hospital GmbH	Lünen
Germany	Universitatsklinikum Muenster	Muenster
Germany	Deutsches Herzzentrum München des Freistaates Bayern	München
Germany	Klinikum Oldenburg	Oldenburg
Germany	Hegau-Bodensee-Hochrhein-Kliniken GmbH	Singen	Baden-Wurttemberg
Germany	Krankenhaus der Barmherzigen Bruder	Trier
Germany	Kliniken Villingen-Schwenningen	Villingen-Schwenningen
Germany	Universitätsklinikum Würzburg	Würzburg
Greece	The Onassis Cardiac Center	Athens
India	Care Institute of Medical Sciences	Ahmedabad
India	Fortis Hospital	Bangalore	Karnataka
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Apollo Hospital	Chennai
India	Medanta - The Medicity Hospital	Gurgaon	Haryana
India	CARE Banjara	Hyderabad
India	Escorts Heart Institute and Research Centre	New Delhi
India	Medanta Medicity Hospital	New Delhi
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Medical Center	Tel Aviv
Italy	Az.Osp.Universitaria Consorziale Policlinico	Bari
Italy	Azienda Ospedaliera Di Venere	Bari
Italy	Policlinico S.Orsola Malpighi	Bologna
Italy	Az. Osp. Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera S. Anna e S Sebastiano	Caserta
Italy	Presidio Osp. Vito Fazzi	Lecce
Italy	Clinica Mediterranea	Naples
Italy	Ospedale dei Pellegrini	Naples
Italy	Ospedale S. Giovanni Bosco	Naples
Italy	Az Osp.Universitaria Maggiore della Carità	Novara
Italy	Università degli Studi di Padova	Padova
Italy	Casa di Cura Dott. Pederzoli	Peschiera del Garda
Italy	Az. Osp. Universitaria Pisana-Presidio Santa Chiara	Pisa
Italy	Ospedale di Portogruaro	Portogruaro
Italy	Azienda Ospedaliera "Civile - Maria Paternò Arezzo"	Ragusa
Italy	Ospedale Madre G. Vannini	Roma
Italy	Policlinico Casilino	Roma
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli di Roma	Rome
Italy	Azienda Ospedaliera S. Anna	San Fermo della Battaglia
Italy	Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Ospedale Civile Maggiore di Verona Borgo Trento	Verona
Korea, Republic of	Sejong General Hospital	Bucheon-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Seocho-gu
Korea, Republic of	Yonsei University Health System	Seoul
Lebanon	American University of Beirut Medical Center	Beirut
Malaysia	Institut Jantung Negara	Kuala Lumpur
Malta	Mater Dei Hospital	Paola
Netherlands	Amsterdam Academic Medical Center (AMC)	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Twee Steden Ziekenhuis	Tilburg	Noord-Brabant
Netherlands	Isala Ziekenhuis	Zwolle
Poland	Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca	Katowice	Slaskie
Poland	Wojewodzki Specjalistyczny Szpital im. Bieganskiego	Lodz
Poland	Szpital Kliniczny Premienienia Panskiego	Poznan	Wielkopolskie
Poland	Slaskie Centrum Chorob Serca	Zabrze	Slask
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar do Alto Ave, Unidade de Guimarães	Creixomil
Portugal	Hospital Garcia de Orta, EPE	Lisboa
Portugal	Hospital de Santa Cruz	Lisbon
Portugal	Santa Maria Hospital	Lisbon
Portugal	Centro Hospitalar Vila Nova Gaia	Vila Nova de Gaia
Puerto Rico	Arrhythmia Group	Ponce
Puerto Rico	Heart Rhythm Management	San Juan
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah
Saudi Arabia	King Fahad Medical City	Riyadh
Singapore	National University Hospital	Singapore
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital de la Santa Creu y Sant Pau	Barcelona
Spain	Hospital Universitario Virgen de la Nieves	Granada
Spain	Complexo Hospitalario Universitario de Santiago	Madrid
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario Doce de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	HCU Virgen de la Victoria	Malaga
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Spain	Hospital Alvaro Cunqueiro	Vigo
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Karolinska University Hospital Huddinge	Stockholm
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
Taiwan	Chang Gung Memorial Hospital	LinKou
Taiwan	National Taiwan University	Taipei City	Taipei
United Kingdom	Wansbeck General Hospital	Ashington
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	The Royal Sussex Country Hospital	Brighton
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Kings College Hospital	London
United Kingdom	St. Thomas Hospital	London
United Kingdom	Manchester Heart Center, Manchester Royal Infirmary	Manchester
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	The Great Western Hospital	Swindon
United States	McLaren Health Care Corporation	Auburn Hills	Michigan
United States	Comprehensive Cardiovascular	Bakersfield	California
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Samaritan Heart & Vascular Institute - Cardiology Dept.	Corvallis	Oregon
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	St. Elizabeth Medical Center - South Unit	Edgewood	Kentucky
United States	Baylor All Saints Medical Center at Fort Worth	Fort Worth	Texas
United States	Glendale Adventist Medical Center	Glendale	California
United States	St. Francis Hospital	Greenville	South Carolina
United States	Cardiology Associates of Fairfield County, PC	Haddon Heights	New Jersey
United States	Memorial Katy Cardiology Associates	Houston	Texas
United States	Heart Center Research, LLC.	Huntsville	Alabama
United States	Scripps Health	La Jolla	California
United States	Colorado Heart & Vascular, P.C.	Lakewood	Colorado
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Baptist Health Lexington	Lexington	Kentucky
United States	Vivek Mangla, MD	Lufkin	Texas
United States	Coliseum Medical Centers	Macon	Georgia
United States	Methodist University Hospital	Memphis	Tennessee
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	MidMichigan Medical Center-Midland	Midland	Michigan
United States	CHI Health Creighton University Medical Center-Bergan Mercy	Omaha	Nebraska
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Cardiac Rhythm Specialists, Inc.	Reseda	California
United States	Redmond Regional Medical Center	Rome	Georgia
United States	San Diego Cardiac Center	San Diego	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	EP Heart	The Woodlands	Texas
United States	Munson Medical Center	Traverse City	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Colombia,  Denmark,  Finland,  France,  Germany,  Greece,  India,  Israel,  Italy,  Korea, Republic of,  Lebanon,  Malaysia,  Malta,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Saudi Arabia,  Singapore,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Non-responder Patients Who Converted to Responders	The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.	Non-responder to responder conversion rate between randomization at 6 months and 12 months
Secondary	Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase	Reduction of LVESV between baseline and 6 Months visit	Baseline vs 6 Months
Secondary	Clinical Composite Score Evaluation	Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,; Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation; Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation; Unchanged: the patient was neither improved nor worsened	Baseline vs 12 Months
Secondary	Reverse Left Ventricular (LV) Remodeling	Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months	Baseline vs 12 Months
Secondary	NYHA Class Changes	Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.	Baseline vs 12 Months
Secondary	6MWT Changes	Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU	Baseline vs 12 Months
Secondary	Patient's QoL Score Changes (MLWHF)	Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).	Baseline vs 12 Months