Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
Recruiting · NCT04088071 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Catheter ablation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
60 locations listed across 31 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Grandview Medical Center - Birmingham, Alabama, United States
- Cardiology Associates of Mobile - Mobile, Alabama, United States
- Valley Heart Rhythm Specialists - Chandler, Arizona, United States
- Pima Heart and Vascular - Tucson, Arizona, United States
- Arrhythmia Research Group - Jonesboro, Arkansas, United States
- Keck School of Medicine - Los Angeles, California, United States
- Santa Barbara Cottage Hospital - Santa Barbara, California, United States
- Community Memorial Hospital - Ventura, California, United States
- University HealthCare Alliance - Walnut Creek, California, United States
- The Medical Center of Aurora - Aurora, Colorado, United States
- Colorado Heart and Vascular - Golden, Colorado, United States
- South Denver Cardiology - Littleton, Colorado, United States
- Ascension St. Vincent's - Jacksonville, Florida, United States
- HCA Florida Mercy Hospital - Miami, Florida, United States
- Naples Community Hospital - Naples, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Sarasota Memorial Hospital - Sarasota, Florida, United States
- Baycare Health Tampa - Tampa, Florida, United States
- Baycare Health System - Winterhaven, Florida, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- Memorial Health University Medical Center - Savannah, Georgia, United States
- The Queen's Medical Center - Honolulu, Hawaii, United States
- Northshore University Health System - Evanston, Illinois, United States
- Midwest Cardiovascular Institute - Naperville, Illinois, United States
- Prairie Education and Research - Springfield, Illinois, United States
- Ascension St. Vincent's Hospital - Indianapolis, Indiana, United States
- University of Iowa - Iowa City, Iowa, United States
- Norton Heart Specialists - Louisville, Kentucky, United States
- Baptist Health Louisville - Saint Matthews, Kentucky, United States
- Maine Medical Center - Portland, Maine, United States
- Capitol CArdiology - Lanham, Maryland, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Henry Ford Health - Detroit, Michigan, United States
- McLaren Greater Lansing - Lansing, Michigan, United States
- Sparrow Clinical Research - Lansing, Michigan, United States
- William Beaumont Hospital - Royal Oak, Michigan, United States
- Michigan Heart - Ypsilanti, Michigan, United States
- Mississippi Baptist Medical Center - Jackson, Mississippi, United States
- University of Missouri - Columbia, Missouri, United States
- CoxHealth - Springfield, Missouri, United States
- Cardiovascular Associates of the Delaware Valley - Haddon Heights, New Jersey, United States
- Lovelace Health System - Albuquerque, New Mexico, United States
- Columbia University Medical Center / NewYork-Presbyterian Hospital (CUMC/NYPH) - New York, New York, United States
- Nuvance Health - Poughkeepsie, New York, United States
- Crouse Health System and Crouse Medical Practice - Syracuse, New York, United States
- Mission Hospital - Asheville, North Carolina, United States
- Novant Health Forsyth Medical Center - Winston-Salem, North Carolina, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- The Christ Hospital - Cincinnati, Ohio, United States
- Mount Carmel Columbus Cardiology Consultants - Columbus, Ohio, United States
- Oklahoma Heart Hospital - Oklahoma City, Oklahoma, United States
- Lancaster General Hospital - Lancaster, Pennsylvania, United States
- University of Pennsylvania, Penn Presbyterian Medical Center - Philadelphia, Pennsylvania, United States
- Allegheny Health Network - Pittsburgh, Pennsylvania, United States
- WellSpan Health - York, Pennsylvania, United States
- Upstate Cardiology - Greenville, South Carolina, United States
- Carolina Cardiology Associates and OnSite Clinical Solutions - Rock Hill, South Carolina, United States
- Baylor Scott & White Research Institute - Dallas, Texas, United States
- Medical City Dallas Hospital - Dallas, Texas, United States
Showing 60 of 70 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →