Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli (TRAVERSE)
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|ClinicalTrials.gov Identifier: NCT03946072|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neurocognitive Dysfunction||Procedure: Transseptal Aortic Approach Catheter Ablation Procedure Procedure: Retrograde Aortic Approach Catheter Ablation Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-center Comparative Effectiveness RCT to Assess a Transseptal Approach to Left Ventricular Ablation Compared to a Retrograde Aortic Approach to Prevent Cerebral Emboli & Neurocognitive Decline in Adults With VT and/or PVCs|
|Actual Study Start Date :||July 2, 2019|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Active Comparator: Transseptal Group
Transseptal Aortic Approach Catheter Ablation Procedure
Procedure: Transseptal Aortic Approach Catheter Ablation Procedure
The transseptal approach entails obtaining femoral venous access, and, guided by fluoroscopy and intra-cardiac ultrasound, starting with a transseptal needle or RF device inside the dilator of a long sheath; pulling down until the fossa ovalis in the interatrial septum is engaged on both fluoroscopy and intracardiac echo imaging; once on the left side, the long sheath is advanced over the transseptal needle, the needle and dilator are removed, and the ablation catheter can then be advanced across the mitral valve into the left ventricle.
Active Comparator: Retrograde Group
Retrograde Aortic Approach Catheter Ablation Procedure
Procedure: Retrograde Aortic Approach Catheter Ablation Procedure
The retrograde aortic approach entails obtaining femoral arterial access and leaving a sheath in the femoral artery. Under fluoroscopy, an ablation catheter is then advanced up the ascending aorta where the catheter tip is curved using an internal mechanism controlled on the handle of the catheter to form a large loop (to prevent the tip from traveling down a coronary artery and causing trauma such as a dissection); the curved loop is advanced around the aortic arch and down the ascending aorta. To cross the aortic valve with this loop, the catheter is typically torqued in various directions until it falls through the aortic valve and into the left ventricle.
- cerebral embolic lesion incidence [ Time Frame: on day 1 post-ablation ]incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
- overall neurocognitive function, change [ Time Frame: from baseline (pre-ablation) to 6 months post-ablation ]percent change in overall neurocognitive function score from baseline (pre-ablation). The neurocognitive function examination includes items from the Brain Health Assessment, a validated, multi-domain testing battery aims to detect cognitive impairment in older adults. The TRAVERSE Testing Battery will include the following tests: Favorites (Forms A and B), Match (Forms A and B), Favorites Delay (Forms A and B), Favorites Recognition (Forms A and B), Dot Counting (Forms A and B), Flanker, and Running Dots.
- new cerebral embolic lesions, number [ Time Frame: on day 1 post-ablation ]number of new cerebral embolic lesions per person, measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
- complications related to the ablation procedure, rate [ Time Frame: post-ablation, through Month 6 ]rate of complications related to the ablation procedure
- symptoms specific to VT/ PVC, change [ Time Frame: from pre-ablation to post-ablation, through Month 6 ]change in self-reported symptoms specific to VT/ PVC
- quality of life composite score, change [ Time Frame: from baseline (pre-ablation) to 6 months post-ablation ]change in quality of life score (composite summary points) measured using the Short Form 12-item Survey (SF-12), a validated measure of health status.
- physical activity (MET-min/week), change [ Time Frame: from baseline (pre-ablation) to 6 months post-ablation ]change in total physical activity (MET-min/week) measured using the International Physical Activity Questionnaire (IPAQ) short format questionnaire, validated for physical activity-related energy expenditure.
- recurrent arrhythmias, rate [ Time Frame: at 6 months post-ablation ]rate of recurrent arrhythmias determined as part of routine clinical care, measured using ECG and continuous ECG monitoring, if data is available
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): NCT03946072
|Contact: Trisha F. Hue, PhD||415-476-2300||THue@psg.ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Gregory M Marcus, MD, MAS 415-476-5706 Greg.Marcus@ucsf.edu|
|Principal Investigator:||Gregory Marcus, MD||University of California, San Francisco|