Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

NCT03946072 | Completed DMC

• 1 other identifier: TRAVERSE
• Study Type: interventional
• Target: 153
• Locations: 2 countries
• Sites: 21

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).

Conditions

Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• new cerebral embolic lesions, number

  on day 1 post-ablation

• complications related to the ablation procedure, rate

  post-ablation, through Month 6

• symptoms specific to VT/PVC, change

  from pre-ablation to post-ablation, through Month 6

• quality of life composite score, change

  from baseline (pre-ablation) to 6 months post-ablation

• physical activity (MET-min/week), change

  from baseline (pre-ablation) to 6 months post-ablation

Study Arms (2)

Transseptal Group

ACTIVE COMPARATOR

Transseptal Aortic Approach Catheter Ablation Procedure

Procedure: Transseptal Aortic Approach Catheter Ablation Procedure

Retrograde Group

ACTIVE COMPARATOR

Retrograde Aortic Approach Catheter Ablation Procedure

Procedure: Retrograde Aortic Approach Catheter Ablation Procedure

Interventions

Transseptal Aortic Approach Catheter Ablation Procedure 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.

Transseptal Group

Retrograde Aortic Approach Catheter Ablation Procedure 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.

Retrograde Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years of age
• Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure
• 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
• Life expectancy of at least 1 year
• Willing and able to undergo pre- and post-ablation MRIs
• Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up)
• Willing and able to provide written informed consent

You may not qualify if:

• Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure)
• Any contraindication to MRI (as defined by the institution performing the MRI)
• Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including:
• Severe aortic stenosis
• Mechanical aortic valve
• Clinical contraindication to a transseptal puncture as determined by the treating physician, including:
• Severe Mitral valve stenosis
• Mechanical Mitral valve
• Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture
• Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
• Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
• Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
• 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
• Inability to perform neurocognitive function testing after \> 24 hours free of sedating medications

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (21)

Banner - University Medical Center

Phoenix, Arizona, 85006, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

San Francisco Veterans Affairs (SFVA) Health Care

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Kaiser Permanente - Colorado

Aurora, Colorado, 80014, United States

Location

University of Colorado, Denver

Denver, Colorado, 80204, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Atrium Health/Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Location

Related Publications (1)

• Marcus GM, Tung R, Gerstenfeld EP, Hue TF, Lin F, Cheng J, Weiss JP, Tzou WS, Hsia H, Ehdaie A, Cooper DH, Bunch TJ, Arkles J, Nazer B, Lee A, Hadjis A, Nguyen DT, Chelu MG, Moss J, Hsu JC, Valderrabano M, Bhave PD, Beaser AD, Kanagasundram A, Wazni O, Bradfield J, Wall G, Chang K, Yang M, Montenegro G, Jarrott S, Kramer JH, Kim AS, Morris YM, Dillon WP. Left Ventricular Entry to Reduce Brain Lesions During Catheter Ablation: A Randomized Trial. Circulation. 2025 Apr 15;151(15):1051-1059. doi: 10.1161/CIRCULATIONAHA.124.071352. Epub 2025 Feb 24.

  PMID: 39989365 DERIVED

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Gregory Marcus, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: July 2, 2019
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); CA (1)