CompletedNo phase
Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
Key facts
- Who runs it
- University of California, San Francisco
- Where
- Aurora, Austin, Chicago, Cleveland, Denver, Houston, Los Angeles, Nashville, Palo Alto, Philadelphia, Phoenix, Portland, Salt Lake City, San Diego, San Francisco, St Louis, and Winston-Salem, United StatesSee the 20 sitesAlso in 1 other country, 1 site
- Trial code
- Status
- Completed
- People taking part
- 153 people enrolled
- Started
- 2 Jul 2019
- Ended
- 25 Nov 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Transseptal Aortic Approach Catheter Ablation Procedure
- Retrograde Aortic Approach Catheter Ablation Procedure
- Record updated
- 26 December 2023
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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 take part
- Inability to perform neurocognitive function testing after > 24 hours free of sedating medications
- 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
- 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)
Where in United States
Also in 1 other country, 1 site
- Kaiser Permanente ColoradoAurora, United StatesNo longer taking part
- Texas Cardiac Arrhythmia Research FoundationAustin, United StatesNo longer taking part
- University of ChicagoChicago, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- University of Colorado DenverDenver, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesNo longer taking part
- Houston Methodist Research InstituteHouston, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
- University of California, Los AngelesLos Angeles, United StatesNo longer taking part
- Vanderbilt UniversityNashville, United StatesNo longer taking part
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Banner University Medical CenterPhoenix, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
- University of California San DiegoSan Diego, United StatesNo longer taking part
- San Francisco Veterans Affairs (SFVA) Health CareSan Francisco, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
- Atrium Health/Wake Forest UniversityWinston-Salem, United StatesNo longer taking part
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Transseptal GroupExisting treatment, for comparison
Transseptal Aortic Approach Catheter Ablation Procedure
Treatment: Transseptal Aortic Approach Catheter Ablation Procedure
- Retrograde GroupExisting treatment, for comparison
Retrograde Aortic Approach Catheter Ablation Procedure
Treatment: Retrograde Aortic Approach Catheter Ablation Procedure
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 26 December 2023