100 Participants Needed

VT Ablation Before LVAD Surgery for Arrhythmia

(PIVATAL Trial)

AC
MB
KH
Overseen ByKathy Honsinger
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is VT ablation generally safe for humans?

VT ablation can be associated with risks like thromboembolism (blood clots) and complications related to anticoagulant (blood-thinning) medications. However, specific safety data for VT ablation before LVAD surgery is not well-documented in the provided research.12345

How is the treatment Intra-Op Prophylactic VT ablation different from other treatments for arrhythmia?

Intra-Op Prophylactic VT ablation is unique because it is performed during the surgery to implant a left ventricular assist device (LVAD), targeting ventricular tachycardia (a type of fast heart rhythm) that may occur after the device is placed. This approach aims to prevent arrhythmias by addressing them directly during the LVAD surgery, which is different from other treatments that are typically done separately and after the device implantation.24678

What data supports the effectiveness of the treatment Intraoperative Ventricular Tachycardia Ablation for arrhythmia?

Research suggests that performing intraoperative ventricular tachycardia (VT) ablation during left ventricular assist device (LVAD) implantation may reduce the recurrence of VT and improve outcomes for patients with advanced heart failure. Additionally, case studies have shown that VT ablation can be effective in reducing VT episodes in patients with structural heart disease, potentially leading to better management of arrhythmias.25679

Who Is on the Research Team?

DH

David Huang, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am older than 18 years.
My heart is very weak, and I am approved for a device to help it pump.
I have had a long-lasting episode of irregular heartbeat in the last 5 years.
See 1 more

Exclusion Criteria

I cannot or do not want to give permission for treatment.
I had a successful VTA ablation before my LVAD implant, with no VTA recurrence.
Participation in other clinical trials (observational registries are allowed with approval)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intra-operative VTA ablation or conventional medical management during LVAD implant

2-4 weeks
In-hospital stay for LVAD implant and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including arrhythmia data and adverse events

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Conventional Management
  • Intra-Op Prophylactic VT ablation
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-Op Prophylactic VT ablationExperimental Treatment1 Intervention
Group II: Conventional ManagementActive Control1 Intervention

Intra-Op Prophylactic VT ablation is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Intraoperative VT Ablation for:
🇪🇺
Approved in European Union as Prophylactic Intraoperative VT Ablation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

Catheter ablation is an effective treatment for ventricular tachycardia (VT) in patients with structural heart disease, helping to reduce the recurrence of VT and the need for implantable cardioverter defibrillator shocks.
This case demonstrates successful VT ablation in a patient with a left ventricular assist device (LVAD) using electroanatomic mapping, suggesting that ablation can be a viable option even in patients where VT is hemodynamically tolerated.
Catheter ablation of electrical storm in a patient with left ventricular assist device.Schade, A., Nentwich, K., Deneke, T.[2021]
This study is a prospective, multicenter, randomized-controlled trial involving 100 patients with advanced heart failure and a history of ventricular tachyarrhythmia (VTA), aiming to evaluate the effectiveness of a novel intra-operative VTA ablation protocol during LVAD implantation.
The primary goal is to determine if this ablation technique can reduce the recurrence of VTA and improve clinical outcomes over an 18-month follow-up period, potentially leading to better management of patients with advanced heart failure.
Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.Huang, DT., Gosev, I., Wood, KL., et al.[2023]
In a study of 112 patients undergoing ventricular tachycardia (VT) ablation, those on uninterrupted oral anticoagulation (OAC) showed a stable coagulation status post-procedure, suggesting that OAC may reduce the risk of thromboembolic events.
Patients not receiving OAC exhibited a significant increase in coagulation markers after the procedure, indicating a heightened prothrombotic response, which underscores the importance of anticoagulation management in VT ablation.
Coagulation Response and Prothrombotic Effect of Uninterrupted Oral Anticoagulant Administration After Catheter Ablation for VT.Yanagisawa, S., Inden, Y., Riku, S., et al.[2022]

Citations

Catheter ablation of electrical storm in a patient with left ventricular assist device. [2021]
Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial. [2023]
Coagulation Response and Prothrombotic Effect of Uninterrupted Oral Anticoagulant Administration After Catheter Ablation for VT. [2022]
Open-chest epicardial ablation of ventricular tachycardia during a left ventricular assist device implantation: a case report. [2023]
Argon laser ablation of malignant ventricular tachycardia associated with coronary artery disease. [2019]
Ventricular Tachycardia Ablation in the Presence of Left Ventricular Thrombus: Safety and Efficacy. [2022]
Anticoagulation and the risk of complications in ventricular tachycardia and premature ventricular complex ablation. [2019]
Thromboembolic prophylaxis protocol with warfarin after radiofrequency catheter ablation of infarct-related ventricular tachycardia. [2019]
[Ablation of ventricular tachycardia in a patient with a left ventricular assist device]. [2021]
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