Back to resultsTransseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli (TRAVERSE)
Primary Purpose
Neurocognitive Dysfunction
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transseptal Aortic Approach Catheter Ablation Procedure
Retrograde Aortic Approach Catheter Ablation Procedure
Sponsored by
About this trial
This is an interventional prevention trial for Neurocognitive Dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Banner - University Medical Center
- Cedars Sinai Medical Center
- University of California, Los Angeles
- Stanford University
- University of California, San Diego
- San Francisco Veterans Affairs (SFVA) Health Care
- University of California, San Francisco
- Kaiser Permanente - Colorado
- University of Colorado, Denver
- University of Chicago
- Washington University in St. Louis
- Atrium Health/Wake Forest University
- Cleveland Clinic
- Oregon Health and Science University
- University of Pennsylvania
- Vanderbilt University
- Texas Cardiac Arrhythmia Research Foundation
- Baylor College of Medicine
- Houston Methodist Research Institute
- University of Utah
- Hôpital du Sacré-Cœur de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transseptal Group
Retrograde Group
Arm Description
Transseptal Aortic Approach Catheter Ablation Procedure
Retrograde Aortic Approach Catheter Ablation Procedure
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
complications related to the ablation procedure, rate
rate of complications related to the ablation procedure
symptoms specific to VT/PVC, change
change in self-reported symptoms specific to VT/PVC
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.
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.
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
Full Information
NCT ID
NCT03946072
First Posted
May 3, 2019
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03946072
Brief Title
Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
Acronym
TRAVERSE
Official Title
Multi-center Comparative Effectiveness Randomized Clinical Trial (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 Ventricular Tachycardia (VT) and/or Premature Ventricular Contractions (PVCs)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2, 2019 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transseptal Group
Arm Type
Active Comparator
Arm Description
Transseptal Aortic Approach Catheter Ablation Procedure
Arm Title
Retrograde Group
Arm Type
Active Comparator
Arm Description
Retrograde Aortic Approach Catheter Ablation Procedure
Intervention Type
Procedure
Intervention Name(s)
Transseptal Aortic Approach Catheter Ablation Procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Retrograde Aortic Approach Catheter Ablation Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
cerebral embolic lesion incidence
Description
incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
Time Frame
on day 1 post-ablation
Title
overall neurocognitive function, change
Description
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.
Time Frame
from baseline (pre-ablation) to 6 months post-ablation
Secondary Outcome Measure Information:
Title
new cerebral embolic lesions, number
Description
number of new cerebral embolic lesions per person, measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
Time Frame
on day 1 post-ablation
Title
complications related to the ablation procedure, rate
Description
rate of complications related to the ablation procedure
Time Frame
post-ablation, through Month 6
Title
symptoms specific to VT/PVC, change
Description
change in self-reported symptoms specific to VT/PVC
Time Frame
from pre-ablation to post-ablation, through Month 6
Title
quality of life composite score, change
Description
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.
Time Frame
from baseline (pre-ablation) to 6 months post-ablation
Title
physical activity (MET-min/week), change
Description
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.
Time Frame
from baseline (pre-ablation) to 6 months post-ablation
Title
recurrent arrhythmias, rate
Description
rate of recurrent arrhythmias determined as part of routine clinical care, measured using ECG and continuous ECG monitoring, if data is available
Time Frame
at 6 months post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Marcus, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner - University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
San Francisco Veterans Affairs (SFVA) Health Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Kaiser Permanente - Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
University of Colorado, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Atrium Health/Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Hôpital du Sacré-Cœur de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
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