Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion
Gregory Marcus

Description

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).

Official Title

Multi-center Comparative Effectiveness RCT to Assess a Transseptal Approach to Left Ventricular Ablation Compared to a Retrograde Aortic Approach to Prevent Cerebral Emboli & Neurocognitive Decline in Adults With VT and/or PVCs

Details

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). Participants will be followed for 6 months post-study procedure. This study will be conducted at up to 12 clinical sites in the United States. A total of one-hundred and fifty (150) participants will be enrolled and randomized.

Keywords

Neurocognitive Dysfunction Cognitive Dysfunction Transseptal Aortic Approach Catheter Ablation Procedure Retrograde Aortic Approach Catheter Ablation Procedure

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Men and women ≥ 18 years of age
  2. Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure
  3. 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
  4. Life expectancy of at least 1 year
  5. Willing and able to undergo pre- and post-ablation MRIs
  6. Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up)
  7. Willing and able to provide written informed consent

You CAN'T join if...

  1. Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure)
  2. Any contraindication to MRI (as defined by the institution performing the MRI)
  3. Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including:
  4. Severe Aortic stenosis
  5. Mechanical aortic valve
  6. Clinical contraindication to a transseptal puncture as determined by the treating physician , including:
  7. Severe Mitral valve stenosis
  8. Mechanical Mitral valve
  9. ASD or PFO closure device that would preclude a transseptal puncture
  10. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
  11. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
  12. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
  13. 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
  14. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist

  • Gregory Marcus
    CLINICAL Dr. Gregory Marcus is a specialist in the treatment of arrhythmias, including mapping and catheter ablation for atrial fibrillation, supraventricular tachycardias and ventricular arrhythmias. He is also an expert in pacemaker, biventricular device and defibrillator implantation. RESEARCH Dr. Marcus is Associate Chief of Cardiology for Research at UCSF Health.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03946072
Study Type
Interventional
Last Updated