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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transseptal Group | Active Comparator | Transseptal Aortic Approach Catheter Ablation Procedure |
|
| Retrograde Group | Active Comparator | Retrograde Aortic Approach Catheter Ablation Procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | on day 1 post-ablation |
| complications related to the ablation procedure, rate |
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Inclusion Criteria:
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:
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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Marcus, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner - University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39989365 | Derived | 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. |
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|
| 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. |
|
rate of complications related to the ablation procedure |
| post-ablation, through Month 6 |
| symptoms specific to VT/PVC, change | change in self-reported symptoms specific to VT/PVC | 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. | 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. | 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 | at 6 months post-ablation |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| University of California, San Diego | San Diego | California | 92093 | United States |
| San Francisco Veterans Affairs (SFVA) Health Care | San Francisco | California | 94121 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Kaiser Permanente - Colorado | Aurora | Colorado | 80014 | United States |
| University of Colorado, Denver | Denver | Colorado | 80204 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Atrium Health/Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Hôpital du Sacré-Cœur de Montréal | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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