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Clinical Trials in Canada / NCT04088071
Recruiting Observational

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

NCT04088071 · tracked via the Priya Life Science Canada tracker
Sponsor
Heart Rhythm Clinical and Research Solutions, LLC
Phase
Observational
Started
2018-01-01
Last updated
2026-09-22

Condition(s) studied

Paroxysmal Atrial FibrillationPersistent Atrial FibrillationVentricular Arrhythmia

Investigational drug(s) / intervention(s)

Catheter ablation

Catheter ablation: Ablation using Biosense Webster, Inc. (BWI) CARTO™ technologies (e.g., THERMOCOOL SMARTTOUCH® SF, QDOT MICRO™, VARIPULSE™). Future new Biosense Webster, Inc. technologies, including new thermal and/or pulsed field ablation (PFA), may be included as they become commercially available.

Study summary

The primary purpose of this Registry is to assess procedural safety and long-term effectiveness of catheter ablations in the treatment of subjects with PAF, PsAF, and VA. The Registry will utilize real world clinical data obtained from the use of commercially available CARTO™ technologies under the authority of a health care practitioner within a legitimate practitioner-subject relationship. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with novel technologies for arrhythmia patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
REAL AF Cohort Inclusion Criteria: * 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. Exclusion Criteria: * 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 CORE VA Cohort Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (75)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Grandview Medical Center Birmingham Alabama Recruiting
Cardiology Associates of Mobile Mobile Alabama Recruiting
Valley Heart Rhythm Specialists Chandler Arizona Recruiting
Pima Heart and Vascular Tucson Arizona Recruiting
Arrhythmia Research Group Jonesboro Arkansas Recruiting
Keck School of Medicine Los Angeles California Recruiting
Santa Barbara Cottage Hospital Santa Barbara California Terminated
Community Memorial Hospital Ventura California Recruiting
University HealthCare Alliance Walnut Creek California Completed
The Medical Center of Aurora Aurora Colorado Recruiting
Colorado Heart and Vascular Golden Colorado Recruiting
South Denver Cardiology Littleton Colorado Recruiting
Ascension St. Vincent's Jacksonville Florida Recruiting
HCA Florida Mercy Hospital Miami Florida Recruiting
Naples Community Hospital Naples Florida Recruiting
Ascension Sacred Heart Pensacola Florida Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
Baycare Health Tampa Tampa Florida Recruiting
Baycare Health System Winterhaven Florida Recruiting
Piedmont Healthcare Atlanta Georgia Recruiting
Memorial Health University Medical Center Savannah Georgia Recruiting
The Queen's Medical Center Honolulu Hawaii Completed
Northshore University Health System Evanston Illinois Recruiting
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Prairie Education and Research Springfield Illinois Recruiting
Ascension St. Vincent's Hospital Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
Norton Heart Specialists Louisville Kentucky Recruiting
Baptist Health Louisville Saint Matthews Kentucky Recruiting
Maine Medical Center Portland Maine Recruiting
Capitol CArdiology Lanham Maryland Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Henry Ford Health Detroit Michigan Recruiting
McLaren Greater Lansing Lansing Michigan Active Not Recruiting
Sparrow Clinical Research Lansing Michigan Recruiting
William Beaumont Hospital Royal Oak Michigan Recruiting
Michigan Heart Ypsilanti Michigan Recruiting
Mississippi Baptist Medical Center Jackson Mississippi Recruiting
University of Missouri Columbia Missouri Recruiting

+ 35 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04088071 on ClinicalTrials.gov ↗ ← All trials in Canada