Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
NCT ID: NCT03946072
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2019-07-02
2023-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Transseptal Group
Transseptal Aortic Approach Catheter Ablation 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.
Retrograde Group
Retrograde Aortic Approach Catheter Ablation 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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gregory Marcus, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Banner - University Medical Center
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Diego
San Diego, California, United States
San Francisco Veterans Affairs (SFVA) Health Care
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente - Colorado
Aurora, Colorado, United States
University of Colorado, Denver
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
Washington University in St. Louis
St Louis, Missouri, United States
Atrium Health/Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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TRAVERSE
Identifier Type: -
Identifier Source: org_study_id