Study Summary
This trial will compare two methods of left ventricular ablation to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia or premature ventricular contractions.
Eligible Conditions
- Neurocognitive Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: at 6 months post-ablation
at 6 months post-ablation
recurrent arrhythmias, rate
Month 6
overall neurocognitive function, change
physical activity (MET-min/week), change
quality of life composite score, change
Month 6
symptoms specific to VT/ PVC, change
symptoms specific to VT/PVC, change
on day 1 post-ablation
cerebral embolic lesion incidence
new cerebral embolic lesions, number
post-ablation, through Month 6
complications related to the ablation procedure, rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Retrograde Group
1 of 2
Transseptal Group
1 of 2
Active Control
150 Total Participants · 2 Treatment Groups
Primary Treatment: Retrograde Group · No Placebo Group · N/A
Retrograde Group
Procedure
ActiveComparator Group · 1 Intervention: Retrograde Aortic Approach Catheter Ablation Procedure · Intervention Types: ProcedureTransseptal Group
Procedure
ActiveComparator Group · 1 Intervention: Transseptal Aortic Approach Catheter Ablation Procedure · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months post-ablation
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,282 Previous Clinical Trials
11,577,459 Total Patients Enrolled
Gregory Marcus, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
3,072 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are willing and able to return and comply with scheduled follow-up visits (through the 6 month follow-up).
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.
You are willing and able to undergo pre- and post-ablation MRIs.
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Conditions
Cancer Related
Treatments