VARIPULSE Catheter Ablation for Atrial Fibrillation

(VIRTUE Trial)

Overseen By Betsy Ellsworth, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivek Reddy

Disqualifiers: Active thrombus, Recent PCI/MI, Infection, Heart failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

141 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.

Research Team

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Adults diagnosed with atrial fibrillation or atypical atrial flutter, who are planning a catheter ablation procedure and can follow the study's requirements. Those with previous ablations for atrial fibrillation may join. Exclusions include active heart infections, recent heart attacks, severe heart failure, clotting issues, pregnant women, and those in other conflicting studies.

Inclusion Criteria

I have been diagnosed with atrial fibrillation or atypical atrial flutter.

Able and willing to provide written consent and comply with all testing and follow-up requirements

I have or will get a device implanted to monitor my heart rhythm.

Exclusion Criteria

I do not have heart conditions that prevent catheter use, like clots or tumors.

I had a heart attack or a procedure to open my heart's arteries within the last month.

I do not have an ongoing serious infection or sepsis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ablation Procedure

Participants undergo anatomical and voltage mapping, activation mapping, and pulmonary vein isolation using the VARIPULSE catheter technology.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ablation procedure, with assessments including emergency room visits, cardioversion, and arrhythmia recurrence.

12 months

Regular follow-up visits (in-person and/or virtual)

Treatment Details

Interventions

• VARIPULSE™ catheter ablation

Trial Overview The trial is testing the VARIPULSE catheter used with TRUPULSE Generator and Carto 3D system to treat atrial fibrillation/flutter during standard ablation procedures. It aims to assess safety and effectiveness of this technology combination.

Participant Groups

Group I: Interventional Experimental Treatment 1 Intervention

All patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device).

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+