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Procedure

VT Ablation Before LVAD Surgery for Arrhythmia (PIVATAL Trial)

Phase 4
Recruiting
Led By Mehmet W Aktas, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Awards & highlights

PIVATAL Trial Summary

This trial is testing whether getting rid of the VTA before LVAD implant surgery can reduce the incidence of VTA afterward.

Who is the study for?
This trial is for adults over 18 with advanced heart muscle disease who are eligible for a heart pump device (LVAD) implant. They must have had or be getting a defibrillator due to past episodes of dangerous heart rhythms within the last 5 years.Check my eligibility
What is being tested?
The study is testing if doing a procedure to prevent irregular heartbeats during LVAD implant surgery can lower the chances of these arrhythmias happening afterward, compared to usual care without this extra procedure.See study design
What are the potential side effects?
Potential side effects may include risks associated with the ablation procedure such as bleeding, infection, and damage to the heart or surrounding structures. There might also be typical surgical risks from LVAD implantation.

PIVATAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

PIVATAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrent VTA
Secondary outcome measures
Mean Length of stay in the intensive care unit after LVAD implant
Mean duration of LVAD implant (and ablation) surgery
Mean duration of ablation
+2 more

PIVATAL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-Op Prophylactic VT ablationExperimental Treatment1 Intervention
Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
Group II: Conventional ManagementActive Control1 Intervention
To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
845 Previous Clinical Trials
534,917 Total Patients Enrolled
2 Trials studying Arrhythmia
150 Patients Enrolled for Arrhythmia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,162 Total Patients Enrolled
42 Trials studying Arrhythmia
9,608 Patients Enrolled for Arrhythmia
Mehmet W Aktas, MDPrincipal InvestigatorUniversity of Rochester

Media Library

Intra-Op Prophylactic VT ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05034432 — Phase 4
Arrhythmia Research Study Groups: Intra-Op Prophylactic VT ablation, Conventional Management
Arrhythmia Clinical Trial 2023: Intra-Op Prophylactic VT ablation Highlights & Side Effects. Trial Name: NCT05034432 — Phase 4
Intra-Op Prophylactic VT ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05034432 — Phase 4
~42 spots leftby Dec 2025
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