Investigating VTA Ablation in Patients with Left Ventricular Assist Devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of ventricular tachycardia (VTA) ablation performed during the implantation of left ventricular assist devices (LVAD) in patients with a history of VTA. It is a multicenter, open-label, randomized-controlled trial enrolling 100 LVAD candidates who will be divided into two groups: one receiving intra-operative VTA ablation and the other receiving standard medical management. Comprehensive data on arrhythmia history and healthcare utilization will be collected, with participants followed for an average of 18 months post-surgery to assess outcomes related to arrhythmia and overall health. The study seeks to determine if VTA ablation can reduce the incidence of VTA after LVAD surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years
* Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
* Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
* History of treated or monitored sustained (i.e., \>30 seconds in duration ) VT or VF episode within the past 5 years.

Exclusion Criteria:

* Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
* Participation in other clinical trials (observational registries are allowed with approval)
* Unable or unwilling to provide informed consent

Where it's running

• Banner University Medical Center
  Phoenix, Arizona, United States Recruiting
• UCLA Cardiac Arrthmia Center
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Medstar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: David Huang, MD — University of Rochester
• Study coordinator: Ann Colasurdo
• Email: ann_colasurdo@urmc.rochester.edu
• Phone: 585-275-1054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.