Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04100148




Registration number
NCT04100148
Ethics application status
Date submitted
20/09/2019
Date registered
24/09/2019
Date last updated
15/03/2024

Titles & IDs
Public title
SyncAV Post-Market Trial
Scientific title
SyncAV Post-Market Trial
Secondary ID [1] 0 0
ABT-CIP-10299
Universal Trial Number (UTN)
Trial acronym
SyncAV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SyncAV programmed ON
Treatment: Devices - Fixed AV delay

Experimental: SyncAV Arm - Treatment Arm

Active Comparator: Fixed AV Delay Arm - Control Arm


Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in left ventricular end systolic volume (LVESV) between baseline and 12 months
Timepoint [1] 0 0
12 months following trial randomization
Secondary outcome [1] 0 0
Percentage of CRT Responders at 12 months
Timepoint [1] 0 0
12 months following trial randomization
Secondary outcome [2] 0 0
Reduction in LVESV in female subjects between baseline and 12 months
Timepoint [2] 0 0
12 months following trial randomization
Secondary outcome [3] 0 0
Percentage of female subjects classified as CRT Responders at 12 months
Timepoint [3] 0 0
12 months following trial randomization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
1400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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District of Columbia
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Georgia
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Iowa
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Kentucky
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Massachusetts
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Michigan
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Mississippi
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Oklahoma
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Virginia
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Montreal
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Nova Scotia
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Quebec
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Canada
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Edmonton
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China
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Heping
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China
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Shaanxi
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China
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Zhejiang
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Colombia
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Antioq
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Finland
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Helsinki
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AQT
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Saxony
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Lisboa
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Puerto Rico
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Ponce
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Russian Federation
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Siberia
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Saudi Arabia
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Riyadh Province
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Saudi Arabia
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Riyadh
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Serbia
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Belgrade
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Singapore
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Central
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Barcelona
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Central Thailand
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Soeast
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South East England
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United Kingdom
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Brighton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niraj Varma, MD
Address 0 0
The Cleveland Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anuja A Kulkarni, MPH
Address 0 0
Country 0 0
Phone 0 0
408 845 8275
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/ct2/show/NCT04100148