Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Neurocognitive Dysfunction Clinical Trial

— TRAVERSE  

Official title:

Multi-center Comparative Effectiveness Randomized Trial to Assess a Transseptal Approach to Left Ventricular Ablation Compared to Retrograde to Prevent Cerebral Emboli & Neurocognitive Decline in Adults With Ventricular Tachycardia/Premature Ventricular Contractions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946072
• Other study ID #: TRAVERSE
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: November 25, 2023

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs).

Description:

This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs). Participants will be followed for 6 months post-study procedure. This study will be conducted at up to 12 clinical sites in the United States. A total of one-hundred and fifty (150) participants will be enrolled and randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women = 18 years of age

2. Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure

3. For this patient, the current plan of the operator must be to pursue a catheter ablation target in the left ventricular endocardium that can be accessed by either a transseptal puncture or retrograde aortic approach

4. Life expectancy of at least 1 year

5. Willing and able to undergo pre- and post-ablation MRIs

6. Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up)

7. Willing and able to provide written informed consent

Exclusion Criteria:

1. Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure)

2. Any contraindication to MRI (as defined by the institution performing the MRI)

3. Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including:

1. Severe aortic stenosis

2. Mechanical aortic valve

4. Clinical contraindication to a transseptal puncture as determined by the treating physician, including:

1. Severe Mitral valve stenosis

2. Mechanical Mitral valve

3. Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture

4. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture

5. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)

6. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)

7. Current mental impairment or other diagnosis which precludes accurate assessment of neurocognitive function or which may not allow patient to understand the nature, significance and scope of the study

8. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Neurocognitive Dysfunction

Intervention

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 radio frequency (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.
• 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.

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Cœur de Montréal	Montréal	Quebec
United States	Kaiser Permanente - Colorado	Aurora	Colorado
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Colorado, Denver	Denver	Colorado
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Research Institute	Houston	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of California, Los Angeles	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner - University Medical Center	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Diego	San Diego	California
United States	San Francisco Veterans Affairs (SFVA) Health Care	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Atrium Health/Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral embolic lesion incidence	incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies	on day 1 post-ablation
Primary	overall neurocognitive function, change	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.	from baseline (pre-ablation) to 6 months post-ablation
Secondary	new cerebral embolic lesions, number	number of new cerebral embolic lesions per person, measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies	on day 1 post-ablation
Secondary	complications related to the ablation procedure, rate	rate of complications related to the ablation procedure	post-ablation, through Month 6
Secondary	symptoms specific to VT/PVC, change	change in self-reported symptoms specific to VT/PVC	from pre-ablation to post-ablation, through Month 6
Secondary	quality of life composite score, change	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.	from baseline (pre-ablation) to 6 months post-ablation
Secondary	physical activity (MET-min/week), change	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.	from baseline (pre-ablation) to 6 months post-ablation
Secondary	recurrent arrhythmias, rate	rate of recurrent arrhythmias determined as part of routine clinical care, measured using ECG and continuous ECG monitoring, if data is available	at 6 months post-ablation