VT Ablation Before LVAD Surgery for Arrhythmia

(PIVATAL Trial)

Recruiting at 18 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether performing a VTA ablation (a procedure to destroy small areas of heart tissue causing abnormal rhythms) during LVAD surgery can reduce heart rhythm problems afterward. The trial compares this approach to the usual medical management (Conventional Management) for individuals with advanced heart conditions. It seeks participants with advanced heart failure who are eligible for LVAD surgery, have a history of specific heart rhythm issues, and already have or are receiving a specific type of heart device. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that intraoperative prophylactic VT ablation during LVAD surgery is generally safe. In one study, 38% of patients experienced a return of their fast heart rhythm, but only 8% faced problems directly related to the procedure. Additionally, 56% of patients did not have further episodes of this heart rhythm issue after the treatment.

These results suggest that the treatment is usually well-tolerated, with few procedure-related problems. This type of ablation aims to reduce heart rhythm issues in patients with severe heart failure, improving surgery outcomes. Prospective trial participants may find this information helpful in understanding its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Intra-Op Prophylactic VT ablation is unique because it directly targets the heart's electrical pathways to prevent arrhythmias during LVAD surgery. Unlike the typical approach of using antiarrhythmic drugs like amiodarone or sotalol, this method involves a catheter-based electrophysiology study and ablation, providing a more precise intervention. Researchers are excited about this approach because it has the potential to reduce the reliance on medications and improve outcomes for patients undergoing LVAD procedures by addressing arrhythmias more effectively at the source.

What evidence suggests that Intra-Op Prophylactic VT ablation might be an effective treatment for arrhythmia?

In this trial, participants will be assigned to one of two treatment arms. One arm involves a procedure called VT ablation during LVAD surgery, which can help prevent the recurrence of serious heart rhythm problems. VT ablation targets and stops abnormal heart rhythms, potentially leading to better health outcomes. Although some studies suggest that this preventive procedure doesn't always lower the risk of death or hospital visits, it still helps manage heart rhythm issues. The goal of VT ablation is to improve patient health by reducing the chances of VT, which can otherwise cause complications. Overall, VT ablation proactively manages heart rhythm disorders during surgery. The other arm of the trial involves conventional management, where participants will receive a standardized antiarrhythmic drug regimen to manage heart rhythm issues. ^{1 4 6 7 8}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475893/

Design and characteristics of the prophylactic intra ... Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X19307765

Ventricular Tachycardia Ablation: Past, Present, and Future ... Ventricular tachycardia (VT) ablation targets clinical arrhythmias to prevent recurrence. Although treatment of VT initially required open heart surgery, it has ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jce.70136?af=R

Contemporary Outcomes of Ventricular Tachycardia ... The primary efficacy outcome was the recurrence of ventricular tachycardia (VT), and the primary safety outcome was the rate of procedural ...

4. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.119.043400

Preventive or Deferred Ablation of Ventricular Tachycardia ... CONCLUSIONS: Preventive VT ablation before ICD implantation did not reduce mortality or hospitalization for arrhythmia or worsening heart ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10461400/

Catheter ablation of ventricular tachycardia: strategies to ... There are limited data regarding the effectiveness and safety of post-ablation anticoagulation strategies after VT ablation. In the post op ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05034432

The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) ... This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA.

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.121.010660?doi=10.1161/CIRCEP.121.010660

Intraoperative Ventricular Tachycardia Ablation During Left ... We aimed to assess the VTA burden following intraoperative ablation during LVAD placement among high-risk heart failure patients. Ten patients underwent ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37515396/

Design and characteristics of the prophylactic intra-operative ... Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular ...