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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

Must not have

Unable or unwilling to provide informed consent

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

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot or do not want to give permission for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post lvad implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrent VTA

Secondary study objectives

Mean rate of peri-procedural complication

Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met