Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion

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 Randomized Clinical Trial (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 Ventricular Tachycardia (VT) and/or Premature Ventricular Contractions (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:
    1. Severe aortic stenosis
    2. Mechanical aortic valve
  4. Clinical contraindication to a transseptal puncture as determined by the treating physician, including:
    1. Severe Mitral valve stenosis
    2. Mechanical Mitral valve
    3. Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture
    4. Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
  5. Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
  6. Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
  7. 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
  8. Inability to perform neurocognitive function testing after > 24 hours free of sedating medications

Locations

  • University of California, San Diego
    San Diego California 92093 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03946072
Study Type
Interventional
Participants
About 153 people participating
Last Updated