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

Prevention

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

Yes

Minimum Age

18 Years

Maximum Age

N/A

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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