VT Ablation Before LVAD Surgery for Arrhythmia

(PIVATAL Trial)

Overseen By Kathy Honsinger

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Rochester

Disqualifiers: Past successful VTA ablation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

100 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 3 4 8 9}

Research Team

David Huang, MD

Principal Investigator

University of Rochester

Eligibility Criteria

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Intra-Op Prophylactic VT ablation Experimental Treatment 1 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 Management Active Control 1 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

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:

• Prevention of ventricular tachycardia in high-risk LVAD patients

Approved in European Union as Prophylactic Intraoperative VT Ablation for:

• Reduction of ventricular tachycardia incidence in LVAD recipients

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coagulation Response and Prothrombotic Effect of Uninterrupted Oral Anticoagulant Administration After Catheter Ablation for VT. Yanagisawa, S., Inden, Y., Riku, S., et al.[2022]

Intraoperative epicardial mapping and ablation during LVAD implantation can effectively eliminate recurrent ventricular arrhythmias (VAs), as demonstrated in a case study of a 59-year-old female patient who had no VT episodes for 15 months post-surgery without anti-arrhythmic drugs.

The procedure was performed safely, with no complications reported, highlighting the potential of this approach to improve outcomes for patients with advanced heart failure and recurrent VTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-chest epicardial ablation of ventricular tachycardia during a left ventricular assist device implantation: a case report. Fukuzawa, K., Hisamatsu, E., Nakai, H., et al.[2023]

Intraoperative mapping-guided argon laser ablation in 20 patients with refractory ventricular tachycardia (VT) showed a 90% survival rate at 1-year follow-up, indicating its long-term safety and efficacy.

The procedure significantly improved heart function, with the mean left ventricular ejection fraction increasing from 34% to 41% postoperatively, and effectively suppressed VT in all survivors at discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Argon laser ablation of malignant ventricular tachycardia associated with coronary artery disease. Saksena, S., Gielchinsky, I., Tullo, NG.[2019]

Ablation of ventricular tachycardia (VT) in patients with laminated left ventricular thrombus is feasible and shows a success rate similar to that of patients without thrombus, with 75% achieving freedom from VT at one year.

The procedure has an acceptable safety profile, with only one major complication (ischemic stroke) occurring among eight patients, suggesting that the presence of a laminated thrombus should not automatically exclude patients from receiving this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventricular Tachycardia Ablation in the Presence of Left Ventricular Thrombus: Safety and Efficacy. Rao, HB., Yu, R., Chitnis, N., et al.[2022]

In a study of 201 patients undergoing ventricular tachycardia (VT) or premature ventricular complex (PVC) ablation, the use of uninterrupted antithrombotic medications did not significantly increase complication rates, suggesting that these medications can be safely continued during the procedure.

The complication rates were 8.5% for patients on anticoagulation, 6.5% for those on antithrombotics, and 5.6% for those with no antithrombotics, indicating that the type of antithrombotic therapy did not lead to a higher risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticoagulation and the risk of complications in ventricular tachycardia and premature ventricular complex ablation. Lane, JD., Cannie, D., Volkova, E., et al.[2019]

A protocol using low-dose unfractionated heparin (UFH) followed by 3 months of oral anticoagulation after ventricular tachycardia (VT) ablation showed low rates of thromboembolic events (0%) and manageable bleeding risks (only 6% experienced bleeding).

For patients with less extensive ablation, using antiplatelet therapy alone was effective, indicating that a tailored approach to thromboembolic prophylaxis can be safely implemented based on the extent of the ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thromboembolic prophylaxis protocol with warfarin after radiofrequency catheter ablation of infarct-related ventricular tachycardia. Siontis, KC., Jamé, S., Sharaf Dabbagh, G., et al.[2019]

The use of left ventricular assist devices (LVADs) is becoming more common for patients awaiting heart transplants or those who cannot undergo transplantation, but nearly 50% of these patients experience ventricular arrhythmias within the first year after implantation.

A history of ventricular arrhythmias before receiving an LVAD is a strong predictor of future arrhythmias, highlighting the need for careful monitoring and potential ablation procedures, although clinical data on such interventions in LVAD patients is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ablation of ventricular tachycardia in a patient with a left ventricular assist device]. Şimşek, E., Özcan, EE., Demir, E., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Catheter ablation of electrical storm in a patient with left ventricular assist device. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Coagulation Response and Prothrombotic Effect of Uninterrupted Oral Anticoagulant Administration After Catheter Ablation for VT. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Open-chest epicardial ablation of ventricular tachycardia during a left ventricular assist device implantation: a case report. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Argon laser ablation of malignant ventricular tachycardia associated with coronary artery disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Ventricular Tachycardia Ablation in the Presence of Left Ventricular Thrombus: Safety and Efficacy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Anticoagulation and the risk of complications in ventricular tachycardia and premature ventricular complex ablation. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Thromboembolic prophylaxis protocol with warfarin after radiofrequency catheter ablation of infarct-related ventricular tachycardia. [2019]

9. Turkey pubmed.ncbi.nlm.nih.gov

[Ablation of ventricular tachycardia in a patient with a left ventricular assist device]. [2021]