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Observational Study of Catheter Ablation for Arrhythmias

This observational study is looking at the real-world experiences of people undergoing catheter ablation for arrhythmias (irregular heartbeats). Specifically, it's focusing on paroxysmal atrial fibrillation (AF episodes that stop on their own within 7 days), persistent atrial fibrillation (AF lasting longer than 7 days but less than a year), and ventricular arrhythmia (irregular heartbeats starting in the lower chambers of the heart). The study uses commercially available Biosense Webster, Inc. CARTO™ technologies like THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, and VARIPULSE™. Researchers want to understand how safe and effective these ablation procedures are at 90 days and 12 months after treatment, and also look at long-term safety 30 days after the procedure. You might be able to join if you are over 18, have symptomatic AF or VA, and your doctor believes you are a candidate for catheter ablation using these technologies.

Study design
This is an observational, prospective, multi-center, non-randomized study planning to enroll 20,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess effectiveness at 90 days and 12 months, and for long-term safety at 30 days post-ablation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04088071

Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias

Recruiting
Not specifiedAges 18+Observational
Heart Rhythm Clinical and Research Solutions, LLC
~20,000 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Catheter ablation

At a glance

Recruiting sites
66 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness at 90 days
Measured over 90 days
+2 more outcomes measured

Conditions

Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Ventricular Arrhythmia

Explore related trials

Paroxysmal Atrial FibrillationPersistent atrial fibrillationVentricular Arrhythmia

NCT04088071

Where you'd take part

This study runs at 70 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baycare Health Tampa

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Crouse Health System and Crouse Medical Practice

    Syracuse, New Yorkstudy coordinator listed

    Recruiting

  • Midwest Cardiovascular Institute

    Naperville, Illinoisstudy coordinator listed

    Recruiting

  • Mount Carmel Columbus Cardiology Consultants

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Pima Heart and Vascular

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Alberta Health

    Edmonton, Alberta, Canadano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jennifer White, MS
[email protected]
1-629-335-8261
Email the study team

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Eligibility criteria

Inclusion

Symptomatic PAF (AF episode terminate spontaneously within 7 days) or PsAF (AF sustained beyond 7 days, but less than 365 days) subjects who, in the opinion of the investigator, are candidates for catheter ablation.
\>18 years of age.
Will be treated with Biosense Webster Inc. ablation technologies
All AF ablations performed with BWI catheters are included. This includes repeat ablations where the index procedure was performed with a non-BWI catheter.
Able and willing to participate in baseline and follow up evaluations
Willing and able to provide informed consent, if applicable.
Documented ventricular arrhythmia appropriate for catheter ablation.
\>18 years of age.
Will be treated with Biosense Webster Inc. ablation technologies
Able and willing to participate in baseline and follow up evaluations
Willing and able to provide informed consent, if applicable.

Exclusion

Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
Long-standing persistent AF (AF greater than one year)
In the opinion of the investigator, any known contraindication to an ablation procedure
Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
In the opinion of the investigator, any known contraindication to an ablation procedure.

What this trial measures

  • Effectiveness at 90 days90 days

    Freedom from arrhythmia recurrence at 90 days post procedure.

  • Effectiveness at 12 months12 months

    Freedom from subject reported arrhythmia recurrence through 12 months post procedure.

  • Long-term Safety30 days post ablation

    Incidence of late onset complications, 30 days post-ablation which are procedure and/or device related