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SyncAV Post-Market Trial (SyncAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100148
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: SyncAV programmed ON Device: Fixed AV delay Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SyncAV Post-Market Trial
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : April 25, 2023
Estimated Study Completion Date : October 30, 2023

Arm Intervention/treatment
Experimental: SyncAV Arm
Treatment Arm
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.

Active Comparator: Fixed AV Delay Arm
Control Arm
Device: 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.




Primary Outcome Measures :
  1. Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months [ Time Frame: 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 :
  1. Percentage of CRT Responders at 12 months [ Time Frame: 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.

  2. Reduction in LVESV in female subjects between baseline and 12 months [ Time Frame: 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.

  3. Percentage of female subjects classified as CRT Responders at 12 months [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100148


Locations
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United States, Arizona
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States, 85016
United States, California
Marin General Hospital
Greenbrae, California, United States, 94904
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Michigan
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48912
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
South Texas Cardiovascular Consultants
San Antonio, Texas, United States, 78201
India
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, Karnataka, India, 560099
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Niraj Varma, MD The Cleveland Clinic
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04100148    
Other Study ID Numbers: ABT-CIP-10299
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abbott Medical Devices:
SyncAV feature
CRT optimization
CRT non-responders
ECG optimization
Cardiac remodeling
CRT with SyncAV
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases