SyncAV Post-Market Trial

Not Applicable

Active, not recruiting

• Conditions: Congestive Heart Failure
• Interventions: Device: Fixed AV delay; Device: SyncAV programmed ON

• Registration Number: NCT04100148
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2019-10-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1686

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed AV Delay Arm	Fixed AV delay	Control Arm
SyncAV Arm	SyncAV programmed ON	Treatment Arm

Primary Outcome Measures

Name	Time	Method
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months	12 months following trial randomization	Reduction of LVESV as a continuous variable from baseline to 12 months compared between subjects in the SyncAV and fixed AV delay arms.

Secondary Outcome Measures

Name	Time	Method
Percentage of CRT Responders at 12 months	12 months following trial randomization	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.
Reduction in LVESV in female subjects between baseline and 12 months	12 months following trial randomization	Reduction of LVESV as a continuous variable from baseline to 12 months compared between female subjects in the SyncAV and fixed AV delay arms.
Percentage of female subjects classified as CRT Responders at 12 months	12 months following trial randomization	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.

Trial Locations

Locations (102)

Azienda Ospedaliera Universitaria MaterDomini; 🇮🇹 Catanzaro, Calabria, Italy

Azienda Ospedaliera S. G. Moscati; 🇮🇹 Avellino, Italy

Chiba University; 🇯🇵 Chiba-shi, Chiba, Japan

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan

Southampton University Hospital; 🇬🇧 Southampton, Soeast, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, South East England, United Kingdom

The Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

HCU Virgen de la Victoria; 🇪🇸 Málaga, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Karolinska University Hospital, Solna; 🇸🇪 Stockholm, Sweden

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Phramongkutklao Hospital; 🇹🇭 Bangkok, Central Thailand, Thailand

Hightower Clinical; 🇺🇸 Oklahoma City, Oklahoma, United States

Max Super Specialty Hospital; 🇮🇳 New Delhi, India

Mater Dei Hospital; 🇮🇹 Bari, Apulia, Italy

Azienda Ospedaliera Di Venere; 🇮🇹 Carbonara, Apulia, Italy

Heart Center Research, LLC.; 🇺🇸 Huntsville, Alabama, United States

Arizona Cardiovascular Research Center; 🇺🇸 Phoenix, Arizona, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Comprehensive Cardiovascular; 🇺🇸 Bakersfield, California, United States

Cardiovascular Consultants Heart Center; 🇺🇸 Fresno, California, United States

USC University Hospital; 🇺🇸 Los Angeles, California, United States

Colorado Heart & Vascular, P.C.; 🇺🇸 Lakewood, Colorado, United States

Shands at the University of Florida; 🇺🇸 Gainesville, Florida, United States

Heart Rhythm Solutions; 🇺🇸 Hollywood, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

Baptist Health Lexington; 🇺🇸 Lexington, Kentucky, United States

Sparrow Clinical Research Institute; 🇺🇸 Lansing, Michigan, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States

Deborah Heart & Lung Center; 🇺🇸 Brown Mills, New Jersey, United States

Cardiovascular Associates of the Delaware Valley; 🇺🇸 Haddon Heights, New Jersey, United States

Lourdes Cardiology Services; 🇺🇸 Voorhees Township, New Jersey, United States

New York Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

The Toledo Hospital; 🇺🇸 Toledo, Ohio, United States

Hospital Puerta de Hierro - Hospital Universitario; 🇪🇸 Madrid, Spain

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, 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

South Texas Cardiovascular Consultants; 🇺🇸 San Antonio, Texas, United States

Heart Rhythm Associates; 🇺🇸 Shenandoah, Texas, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

Universitätsklinik Graz; 🇦🇹 Graz, Styria, Austria

Hopital Erasme; 🇧🇪 Brussels, Belgium

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montréal, Montreal, Canada

HSC, Eastern Health; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada

QE II Health Sciences; 🇨🇦 Halifax, Nova Scotia, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

St. Mary's General Hospital; 🇨🇦 Kitchener, Ontario, Canada

Cardiac Arrhythmia Research Group Inc. (CARGI); 🇨🇦 Scarborough, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.); 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre General Hospital; 🇨🇦 Montréal, Quebec, Canada

CHUS Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Canada

CHUM; 🇨🇦 Montreal, Canada

Institut de Cardiologie de Quebec (Hôpital Laval); 🇨🇦 Quebec, Canada

Tianjin Chest Hospital; 🇨🇳 Tianjin, Heping, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Helsinki University Central Hospital (HYKS); 🇫🇮 Helsinki, Finland

Hopital Henri Mondor; 🇫🇷 Creteil, Ile-de-France, France

CHR de La Reunion - Site du CHFG; 🇫🇷 Saint-Denis Cedex, Ile-de-France, France

CHU Rangueil Toulouse; 🇫🇷 Toulouse, Midi-Pyrenees, France

CHRU Hopital de Pontchaillou; 🇫🇷 Rennes, France

St-Etienne CHU; 🇫🇷 Saint-Priest-En-Jarez, France

Klinikum der Ruprecht-Karls-Universität Heidelberg; 🇩🇪 Heidelberg, Bad-wur, Germany

Herzzentrum Dresden GmbH Universitätsklinik; 🇩🇪 Dresden, Saxony, Germany

Kerckhoff-Klinik gGmbH; 🇩🇪 Bad Nauheim, Germany

The University of Hong Kong (Queen Mary Hospital); 🇭🇰 Hong Kong, Hong Kong

Asian Institute of Gastroenterology (AIG) Hospital; 🇮🇳 Hyderabad, Andprad, 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

St. Marianna University School of Medicine Hospital; 🇯🇵 Kawasaki, Kanagawa-Ken, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara, Kanagwa, Japan

Sejong Hospital; 🇰🇷 Bucheon, 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, Korea, Republic of

Amsterdam Academic Medical Centre (AMC); 🇳🇱 Amsterdam, Noord-h, Netherlands

Scanmed SA; 🇵🇱 Krakow, Lesrpld, Poland

Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu; 🇵🇱 Poznań, Poland

Santa Maria Hospital; 🇵🇹 Lisboa, Portugal

Arrhythmia Group LLC; 🇵🇷 Ponce, Puerto Rico

Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Siberia, Russian Federation

King Fahad Armed Forces Hospital; 🇸🇦 Jeddah, Makkah, Saudi Arabia

King Faisal Specialist Hospital (KFSH); 🇸🇦 Riyadh, Riyadh Province, Saudi Arabia

King Fahad Medical City; 🇸🇦 Riyadh, Saudi Arabia

Clinical Center of Serbia - Pacemaker Center; 🇷🇸 Belgrade, Serbia

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain