VARIPULSE Catheter Ablation for Atrial Fibrillation (VIRTUE Trial)

N/A

Waitlist Available

Led By Vivek Reddy, MD

Research Sponsored by Vivek Reddy

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm

Age 18 or older

Must not have

Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.

Previous PCI/MI within the past 1 month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 3-month blanking period until end of 12 months of follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses the safety, performance and effectiveness of a new catheter and generator combo to treat atrial fibrillation and related arrhythmias during ablation procedures.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks of catheter ablation can include bleeding or infection at the catheter insertion site, damage to blood vessels or heart tissue, arrhythmias complications or reactions related to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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I am scheduled for a procedure to correct heart rhythm.

Exclusion Criteria

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

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

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

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I do not have an ongoing serious infection or sepsis.

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I am not pregnant, breastfeeding, or planning to become pregnant during the trial.

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I do not have severe heart failure that limits my daily activities.

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I have a history of blood clotting or bleeding issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 3-month blanking period until end of 12 months of follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 3-month blanking period until end of 12 months of follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 3-month blanking period until end of 12 months of follow-up for reporting.