Retrograde Group for Neurocognitive Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neurocognitive DisorderRetrograde Aortic Approach Catheter Ablation Procedure - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Procedure
Transseptal Group
Procedure
ActiveComparator Group · 1 Intervention: Transseptal Aortic Approach Catheter Ablation Procedure · Intervention Types: Procedure

Trial 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.