SyncAV Post-Market Trial

Congestive Heart Failure Clinical Trial

— SyncAV  

Official title:

SyncAV Post-Market Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04100148
• Other study ID #: ABT-CIP-10299
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

Description:

The SyncAV Post-Market Trial is designed as a prospective, randomized, multi-center trial. The trial will require physicians to implant an Abbott CRT device and Abbott Quadripolar LV lead with any available right atrial and right ventricular leads. Sites will randomize subjects in a 1:1 ratio within 2 - 6 weeks post successful CRT implant: Arm 1 - SyncAV CRT programmed ON; Arm 2 - programmed fixed atrioventricular (AV) delay.

For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at biventricular (BiV) pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.

For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.

Sites will collect data at baseline (before CRT implant), randomization, and at 3-month, 6-month, and 12-month visits. For subjects randomized to the SyncAV ON arm, sites will optimize the SyncAV feature again at 3 months and 6 months in the same manner as the randomization visit.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1686
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Scheduled to receive a new CRT implant or an upgrade (Abbott CRT device and Abbott Quadripolar LV lead) from an existing implantable cardioverter defibrillator/pacemaker implant with no more than 10% RV pacing at the last device interrogation, no prior LV lead placement, AND meet the following additional criteria:

1. Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist

2. LVEF = 35% based on a prior standard of care echocardiogram

3. Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,

i. QRS duration = 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval = 280 ms on surface ECG)

2. At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws

3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

1. Recent myocardial infarction or unstable angina within 40 days prior to signing consent

2. Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent

3. Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent

4. Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent

5. Permanent or persistent AF at the time of signing consent

6. Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent

7. Prior CRT device implant

8. Prior His Bundle pacing implant or plan to have His Bundle pacing implant

9. Pregnant or breastfeeding at the time of signing consent

10. Incapacitated or unable to read or write

11. Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period

12. Life expectancy < 12 months due to any condition

13. Unavailable for at least 12 months of follow-up visits

14. Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• SyncAV programmed ON
For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
• Fixed AV delay
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.

Locations

Country	Name	City	State
Austria	Universitätsklinik Graz	Graz	Styria
Belgium	Hopital Erasme	Brussels
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton
Canada	QE II Health Sciences	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	St. Mary's General Hospital	Kitchener	Ontario
Canada	CHUM	Montreal
Canada	Hopital du Sacre-Coeur de Montreal	Montréal	Montreal
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	McGill University Health Centre General Hospital	Montréal	Quebec
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec
Canada	HSC, Eastern Health	Saint John's	Newfoundland and Labrador
Canada	Cardiac Arrhythmia Research Group Inc. (CARGI)	Scarborough	Ontario
Canada	CHUS Fleurimont	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Tianjin Chest Hospital	Tianjin	Heping
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
Finland	Helsinki University Central Hospital (HYKS)	Helsinki
France	Hopital Henri Mondor	Creteil	Ile-de-France
France	CHRU Hopital de Pontchaillou	Rennes
France	CHR de La Reunion - Site du CHFG	Saint-Denis Cedex	Ile-de-France
France	St-Etienne CHU	Saint-Priest-En-Jarez
France	CHU Rangueil Toulouse	Toulouse	Midi-Pyrenees
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden	Saxony
Germany	Klinikum der Ruprecht-Karls-Universität Heidelberg	Heidelberg	Bad-wur
Hong Kong	The University of Hong Kong (Queen Mary Hospital)	Hong Kong
India	Care Institute of Medical Sciences	Ahmedabad	Gujarat
India	Apollo Hospitals, Bangalore	Bangalore	Karnataka
India	Narayana Institute of Cardiac Sciences, Bommasandra	Bangalore	Karnataka
India	Medanta - The Medicity Hospital	Gurgaon
India	Asian Institute of Gastroenterology (AIG) Hospital	Hyderabad	Andprad
India	Max Super Specialty Hospital	New Delhi
Italy	Azienda Ospedaliera S. G. Moscati	Avellino
Italy	Mater Dei Hospital	Bari	Apulia
Italy	Azienda Ospedaliera Di Venere	Carbonara	Apulia
Italy	Azienda Ospedaliera Universitaria MaterDomini	Catanzaro	Calabria
Japan	Chiba University	Chiba-shi	Chiba
Japan	St. Marianna University School of Medicine Hospital	Kawasaki	Kanagawa-Ken
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Kitasato University Hospital	Sagamihara	Kanagwa
Korea, Republic of	Sejong Hospital	Bucheon	Sudogwn
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu	Sudogwn
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Sudogwn
Korea, Republic of	Asan Medical Centre	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Netherlands	Amsterdam Academic Medical Centre (AMC)	Amsterdam	Noord-h
Poland	Scanmed SA	Krakow	Lesrpld
Poland	Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu	Poznan
Portugal	Santa Maria Hospital	Lisboa
Puerto Rico	Arrhythmia Group LLC	Ponce
Russian Federation	Meshalkin National Medical Research Center	Novosibirsk	Siberia
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah	Makkah
Saudi Arabia	King Fahad Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital (KFSH)	Riyadh	Riyadh Province
Serbia	Clinical Center of Serbia - Pacemaker Center	Belgrade
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Puerta de Hierro - Hospital Universitario	Madrid
Spain	HCU Virgen de la Victoria	Málaga
Spain	Hospital Universitario de Salamanca	Salamanca
Sweden	Karolinska University Hospital, Solna	Stockholm
Taiwan	Taichung Veterans General Hospital	Taichung
Thailand	Phramongkutklao Hospital	Bangkok	Central Thailand
United Kingdom	The Royal Sussex County Hospital	Brighton
United Kingdom	John Radcliffe Hospital	Oxford	South East England
United Kingdom	Southampton University Hospital	Southampton	Soeast
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Comprehensive Cardiovascular	Bakersfield	California
United States	New York Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cardiovascular Consultants Heart Center	Fresno	California
United States	Shands at the University of Florida	Gainesville	Florida
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Heart Rhythm Solutions	Hollywood	Florida
United States	CHI St. Luke's Health Baylor College of Medicine Med. Ctr.	Houston	Texas
United States	Memorial Katy Cardiology Associates	Houston	Texas
United States	Heart Center Research, LLC.	Huntsville	Alabama
United States	Colorado Heart & Vascular, P.C.	Lakewood	Colorado
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Baptist Health Lexington	Lexington	Kentucky
United States	USC University Hospital	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	South Texas Cardiovascular Consultants	San Antonio	Texas
United States	HonorHealth	Scottsdale	Arizona
United States	Heart Rhythm Associates	Shenandoah	Texas
United States	The Toledo Hospital	Toledo	Ohio
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  China,  Finland,  France,  Germany,  Hong Kong,  India,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Saudi Arabia,  Serbia,  Spain,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months	Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.	12 months following trial randomization
Secondary	Percentage of CRT Responders at 12 months	Percentage of subjects classified as CRT responders after 12 months of follow-up compared between subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.	12 months following trial randomization
Secondary	Reduction in LVESV in female subjects between baseline and 12 months	Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.	12 months following trial randomization
Secondary	Percentage of female subjects classified as CRT Responders at 12 months	Percentage of female subjects classified as CRT responders after 12 months of follow-up compared between female subjects in the SyncAV and fixed AV delay arms, as measured by LVESV reduction of at least 15% compared to baseline.	12 months following trial randomization