NCT04088071 Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
| NCT ID | NCT04088071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart Rhythm Clinical and Research Solutions, LLC |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2018-01-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04088071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04088071 currently recruiting?
Yes, NCT04088071 is actively recruiting participants. Contact the research team at jwhite@hrcrs.com for enrollment information.
Where is the NCT04088071 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Mobile, United States, Chandler, United States and 11 additional locations.
Who is sponsoring the NCT04088071 clinical trial?
NCT04088071 is sponsored by Heart Rhythm Clinical and Research Solutions, LLC. The trial plans to enroll 20,000 participants.
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