Neurocognitive DysfunctionTRAVERSENCT03946072
Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
A study testing Transseptal Aortic Approach Catheter Ablation Procedure and Retrograde Aortic Approach Catheter Ablation Procedure in people with Neurocognitive Dysfunction, run by University of California, San Francisco at 21 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Dysfunction
- What is being tested?
- Transseptal Aortic Approach Catheter Ablation Procedure and Retrograde Aortic Approach Catheter Ablation Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 2 Jul 2019to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 14Show fewer
- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Kaiser Permanente - Colorado
Aurora, Colorado, 80014
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
University of Colorado, Denver
Denver, Colorado, 80204
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Research Institute
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of California, Los Angeles
Los Angeles, California, 90095
Vanderbilt University
Nashville, Tennessee, 37235
Stanford University
Palo Alto, California, 94305
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner - University Medical Center
Phoenix, Arizona, 85006
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84112
University of California, San Diego
San Diego, California, 92093
San Francisco Veterans Affairs (SFVA) Health Care
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
Washington University in St. Louis
St Louis, Missouri, 63110
Atrium Health/Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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
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).
Read the 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.
- Conditions
- Neurocognitive Dysfunction
- Being tested
- Transseptal Aortic Approach Catheter Ablation Procedure, Retrograde Aortic Approach Catheter Ablation Procedure
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transseptal Aortic Approach Catheter Ablation ProcedureProcedure or surgery
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 ProcedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transseptal Group | Active comparator | Transseptal Aortic Approach Catheter Ablation Procedure Receives: Procedure: Transseptal Aortic Approach Catheter Ablation Procedure |
| Retrograde Group | Active comparator | Retrograde Aortic Approach Catheter Ablation Procedure Receives: Procedure: Retrograde Aortic Approach Catheter Ablation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: from baseline (pre-ablation) to 6 months post-ablation
Secondary outcomes (6)
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
Measured: on day 1 post-ablation
complications related to the ablation procedure, rate
rate of complications related to the ablation procedure
Measured: post-ablation, through Month 6
symptoms specific to VT/PVC, change
change in self-reported symptoms specific to VT/PVC
Measured: from pre-ablation to post-ablation, through Month 6
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.
Measured: from baseline (pre-ablation) to 6 months post-ablation
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.
Measured: from baseline (pre-ablation) to 6 months post-ablation
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
Measured: at 6 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start2 Jul 2019
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Marcus, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946072
- Sponsor's protocol ID
- TRAVERSE
- Acronym
- TRAVERSE
- Status last verified
- Dec 2023
- First submitted
- 3 May 2019
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39989365
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03946072
- Acronym / sponsor ID
- TRAVERSE / TRAVERSE
- Conditions
- Neurocognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transseptal Group | Active comparator | Procedure: Transseptal Aortic Approach Catheter Ablation ProcedureTransseptal Aortic Approach Catheter Ablation Procedure |
| Retrograde Group | Active comparator | Procedure: Retrograde Aortic Approach Catheter Ablation ProcedureRetrograde Aortic Approach Catheter Ablation Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
- Clinical contraindication to a transseptal puncture as determined by the treating physician, including:
- Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transseptal Aortic Approach Catheter Ablation ProcedureThe 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. | Procedure or surgery | Transseptal Group |
| Retrograde Aortic Approach Catheter Ablation ProcedureThe 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. | Procedure or surgery | Retrograde Group |
Primary outcome
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
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.
6 secondary outcomes
new cerebral embolic lesions, number
Time frame: on day 1 post-ablation
complications related to the ablation procedure, rate
Time frame: post-ablation, through Month 6
symptoms specific to VT/PVC, change
Time frame: 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
physical activity (MET-min/week), change
Time frame: from baseline (pre-ablation) to 6 months post-ablation
recurrent arrhythmias, rate
Time frame: at 6 months post-ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 39989365Marcus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Marcus, MD principal investigator
University of California, San Francisco
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transseptal Aortic Approach Catheter Ablation Procedure and Retrograde Aortic Approach Catheter Ablation Procedure in people with Neurocognitive Dysfunction, run by University of California, San Francisco at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral embolic lesion incidence (time frame: on day 1 post-ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.