Status:
ACTIVE_NOT_RECRUITING
SyncAV Post-Market Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ava...
Eligibility Criteria
Inclusion
- 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:
- 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
- LVEF ≤ 35% based on a prior standard of care echocardiogram
- 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)
- At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
- Willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion
- Recent myocardial infarction or unstable angina within 40 days prior to signing consent
- Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
- Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
- 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
- Permanent or persistent AF at the time of signing consent
- Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
- Prior CRT device implant
- Prior His Bundle pacing implant or plan to have His Bundle pacing implant
- Pregnant or breastfeeding at the time of signing consent
- Incapacitated or unable to read or write
- Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
- Life expectancy \< 12 months due to any condition
- Unavailable for at least 12 months of follow-up visits
- 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
Key Trial Info
Start Date :
October 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
1686 Patients enrolled
Trial Details
Trial ID
NCT04100148
Start Date
October 3 2019
End Date
June 30 2026
Last Update
December 18 2025
Active Locations (104)
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1
Heart Center Research, LLC.
Huntsville, Alabama, United States, 35801
2
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States, 85016
3
HonorHealth
Scottsdale, Arizona, United States, 85258
4
Comprehensive Cardiovascular
Bakersfield, California, United States, 93309