SyncAV Post-Market Trial (SyncAV)
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StatusAccepting Candidates
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Age18 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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
Full study title | SyncAV Post-Market Trial |
Protocol number | OCR39635 |
ClinicalTrials.gov ID | NCT04100148 |
Phase | N/A |
Eligibility
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,
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 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
Lead researcher
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William M Miles, MD, FACCCardiologist (Heart Specialist), Clinical Cardiologist - Electrophysiology Specialist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
William Miles -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.