Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias (NCT04088071) | Clinical Trial Compass
RecruitingNot Applicable
Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias
United States, Canada20,000 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness at 90 days
Timeframe: 90 days
2
Effectiveness at 12 months
Timeframe: 12 months
3
Long-term Safety
Timeframe: 30 days post ablation
Trial details
NCT IDNCT04088071
SponsorHeart Rhythm Clinical and Research Solutions, LLC