Open
Actively Recruiting
Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli
About
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).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Study Stats
Protocol No.
19-001577
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Westwood