Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli (TRAVERSE)

• ClinicalTrials.gov Identifier: NCT03946072
• Recruitment Status: Recruiting
• First Posted: May 10, 2019
• Last Update Posted: December 28, 2021
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Neurocognitive Dysfunction	Procedure: Transseptal Aortic Approach Catheter Ablation Procedure; Procedure: Retrograde Aortic Approach Catheter Ablation Procedure	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. 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
2. complications related to the ablation procedure, rate [ Time Frame: post-ablation, through Month 6 ]
   rate of complications related to the ablation procedure
3. 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
4. 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.
5. 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.
6. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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. ASD or 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

Contacts and Locations

Contacts

Contact: Trisha F. Hue, PhD; 415-476-2300; THue@psg.ucsf.edu

Locations

United States, California

Cedars Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Ashkan Ehdaie, MD ashkan.ehdaie@cshs.org

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Contact: Jason Bradfield, MD jbradfield@mednet.ucla.edu

University of California, San Diego; Recruiting

San Diego, California, United States, 92093

Contact: Jonathan Hsu, MD jonathan.hsu@ucsd.edu

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Gregory M Marcus, MD, MAS Greg.Marcus@ucsf.edu

United States, Colorado

University of Colorado, Denver; Recruiting

Denver, Colorado, United States, 80204

Contact: Wendy Tzou, MD wendy.tzou@cuanschultz.edu

United States, Illinois

University of Chicago; Recruiting

Chicago, Illinois, United States, 60637

Contact: Andrew Beaser, MD abeaser@medicine.bsd.uchicago.edu

United States, North Carolina

Atrium Health/Wake Forest University; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Prashant Bhave, MD pbhave@wakehealth.edu

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Ouassama Wazni, MD waznio@ccf.org

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Babak Nazer, MD nazer@ohsu.edu

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Jeffrey Arkles, MD jeffrey.arkles@pennmedicine.upenn.edu

United States, Tennessee

Vanderbilt University; Recruiting

Nashville, Tennessee, United States, 37235

Contact: Arvindh Kanagasundram, MD arvindh.n.kanagasundram@vumc.org

United States, Texas

Houston Methodist Research Institute; Recruiting

Houston, Texas, United States, 77030

Contact: Miguel Valderrabano, MD MValderrabano@houstonmethodist.org

Baylor University; Recruiting

Waco, Texas, United States, 76706

Contact: Mihail Chelu, MD mihail.chelu@bcm.edu

United States, Utah

University of Utah; Recruiting

Salt Lake City, Utah, United States, 84112

Contact: Jared Bunch, MD jared.bunch@hsc.utah.edu

Canada, Quebec

Hôpital du Sacré-Cœur de Montréal; Recruiting

Montréal, Quebec, Canada

Contact: Alexios Hadjis, MD alexios.e.hadjis@gmail.com

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Gregory Marcus, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03946072
• Other Study ID Numbers: TRAVERSE
• First Posted: May 10, 2019
• Last Update Posted: December 28, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders