SyncAV Post-Market Trial (SyncAV)

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    1400
  • sponsor
    Abbott Medical Devices
Updated on 17 June 2022
medical therapy
heart failure
aldosterone
beta blockers
angiotensin
implantable cardioverter-defibrillators
left bundle branch block
cardiac resynchronization therapy

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.

Details
Condition Congestive Heart Failure
Treatment SyncAV programmed ON, Fixed AV delay
Clinical Study IdentifierNCT04100148
SponsorAbbott Medical Devices
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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