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Procedure

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3-month blanking period until end of 12 months of follow-up
Awards & highlights

VIRTUE Trial 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.Check my eligibility
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.See study design
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.

VIRTUE Trial 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.

VIRTUE Trial Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with acute procedural success
Secondary outcome measures
Durability of lesion sets in any patient that undergoes a second procedure
Number of patient Hospitalizations
Number of patient emergency room (ER) visits
+8 more

VIRTUE Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
All patients will receive the intervention. That is, all patients will undergo ablation with the experimental catheter (device).

Find a Location

Who is running the clinical trial?

Vivek ReddyLead Sponsor
20 Previous Clinical Trials
5,206 Total Patients Enrolled
Vivek Reddy, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
33 Previous Clinical Trials
11,146 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation open to enrollment currently?

"According to records available on clinicaltrials.gov, the current trial is no longer recruiting patients. The study was first made visible online on September 28th 2023 and its latest update occurred on September 20th 2023. Nevertheless, there are 514 other studies that require participants at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Vivek Reddy 2023. "Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056557.
~80 spots leftby Dec 2024
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