|

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

RECRUITINGSponsored by Heart Rhythm Clinical and Research Solutions, LLC
Actively Recruiting
SponsorHeart Rhythm Clinical and Research Solutions, LLC
Started2018-01-01
Est. completion2028-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations68 sites

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

Heart DiseaseParoxysmal Atrial FibrillationPersistent Atrial FibrillationVentricular Arrhythmia

Locations68 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35233
Michelle Osoinak
Grandview Medical Center
Birmingham, Alabama, 35243
Susan Thorington
Cardiology Associates of Mobile
Mobile, Alabama, 36695
Lynn Ward
Valley Heart Rhythm Specialists
Chandler, Arizona, 85224
Gianani Cabrera
Pima Heart and Vascular
Tucson, Arizona, 85741

Find trials near these locations

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.