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Transseptal vs Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli

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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
    • ASD or 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

Join this Trial

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Study Stats
Protocol No.
19-001577
Category
Cardiology
Contact
Julie Sorg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03946072
For detailed technical eligibility, visit ClinicalTrials.gov.