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

December 19, 2023 updated by: University of California, San Francisco

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada
        • Hôpital du Sacré-Cœur de Montréal
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Palo Alto, California, United States, 94305
        • Stanford University
      • San Diego, California, United States, 92093
        • University of California, San Diego
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs (SFVA) Health Care
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente - Colorado
      • Denver, Colorado, United States, 80204
        • University of Colorado, Denver
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health/Wake Forest University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37235
        • Vanderbilt University
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
on day 1 post-ablation
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.
from baseline (pre-ablation) to 6 months post-ablation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
on day 1 post-ablation
complications related to the ablation procedure, rate
Time Frame: post-ablation, through Month 6
rate of complications related to the ablation procedure
post-ablation, through Month 6
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
from pre-ablation to post-ablation, through Month 6
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.
from baseline (pre-ablation) to 6 months post-ablation
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.
from baseline (pre-ablation) to 6 months post-ablation
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
at 6 months post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory Marcus, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRAVERSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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