Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

A vizsgálat adatai

Ki végzi

University of California, San Francisco

Azonosító

NCT03946072

A regiszteradat frissítve

2023. december 26.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

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

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).

Bevonási feltételek: 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.

Kizáró feltételek: 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).

ClinicalTrials.gov NCT03946072