Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

Completed · Not applicable

Conditions studied: Neurocognitive Dysfunction

In brief

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).

Key facts

Study ID

NCT03946072

Run by

University of California, San Francisco

People needed

153

Starts

2019-07-02

Expected to finish

2023-11-25

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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