Condition or disease | Intervention/treatment | Phase |
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Neurocognitive Dysfunction | Procedure: Transseptal Aortic Approach Catheter Ablation Procedure Procedure: Retrograde Aortic Approach Catheter Ablation Procedure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Multi-center Comparative Effectiveness 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 VT and/or PVCs |
Actual Study Start Date : | July 2, 2019 |
Estimated Primary Completion Date : | November 1, 2021 |
Estimated Study Completion Date : | December 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Transseptal Group
Transseptal Aortic Approach Catheter Ablation Procedure
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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 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.
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Active Comparator: Retrograde Group
Retrograde Aortic Approach Catheter Ablation Procedure
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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:
Contact: Trisha F. Hue, PhD | 415-476-2300 | THue@psg.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Gregory M Marcus, MD, MAS 415-476-5706 Greg.Marcus@ucsf.edu |
Principal Investigator: | Gregory Marcus, MD | University of California, San Francisco |
Tracking Information | |||||
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First Submitted Date ICMJE | May 3, 2019 | ||||
First Posted Date ICMJE | May 10, 2019 | ||||
Last Update Posted Date | December 7, 2020 | ||||
Actual Study Start Date ICMJE | July 2, 2019 | ||||
Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli | ||||
Official Title ICMJE | Multi-center Comparative Effectiveness 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 VT and/or PVCs | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Neurocognitive Dysfunction | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
150 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 1, 2021 | ||||
Estimated Primary Completion Date | November 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03946072 | ||||
Other Study ID Numbers ICMJE | TRAVERSE | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of California, San Francisco | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of California, San Francisco | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |