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The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal Atrial Fibrillation (PAF) ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF patients.
This is a prospective, observational, multi-center registry. The registry population will include adult subjects with symptomatic PAF that meet all eligibility criteria, who, in the opinion of the investigator, are candidates for AF ablation. The primary purpose of this registry is to obtain "real world" clinical use of commercially available novel RF technologies. The registry will involve the administration of a legally-marketed device(s) under the authority of a health care practitioner within a legitimate practitioner-patient relationship. The process for gathering the data does not influence treatment decisions.
The outcome measures for this registry will assess the following up to 12-months post- ablation: AF monitoring performed, Sleep apnea, post-procedure arrhythmia treatments, AF related symptoms, AAD usage, OAC usage, CHA2DS2VASC, a patient-reported outcome, effectiveness, and procedural complication and long-term safety.
All consecutive patients presenting at the institution considered for an RF ablation procedure for symptomatic PAF should be screened by the investigator or designated member of the research team for study eligibility per the inclusion and exclusion criteria.
Each subject screened for enrollment in the registry who meets all the eligibility criteria will be enrolled into the study. All patients will be treated with commercially approved catheters and ablation will be conducted based on the current standard of care. When necessary, local IRB approval will be obtained, and given that there will be no intervention arm on this study and it is simply an observational study, there is no potential harm to the patients.
Three separate case report forms, and one site questionnaire will be used to collect information about the procedure event, the pre-procedure assessment, 10-12-week follow-up office visit and the 1-year follow-up office visit.
The following data will be collected at the baseline assessment which will be administered within 90 days before the ablation procedure: 1) baseline patient-specific information-- age on date of procedure, gender, height/weight, type of implanted device, Was TEE performed pre-ablation, was ICE used for LAA clot evaluation, HAS-BLED, CHADSVAS, Sleep Apnea diagnosis and if compliance, Year of first afib diagnosis, and whether the case is a repeat ablation; 2) procedure details-- case-specific details and Carto data associated with the case; and 3) af symptoms, af documentation method, pre-procedure af treatment history, Sleep apnea, TTE (within 6 months from procedure), current AAD, previously failed AAD, Beta-blocker usage, and pre-ablation OAC usage.
The following data will be collected at the 10-12 week follow-up office visit: Patient Weight, AAD status, OAC usage, TTE, Procedural and peri-procedural complications, and documented AF prior to visit.
The following data will be collected at the 12-month post-procedural assessment: Patient Weight, AF monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms, AAD usage, OAC usage, CHA2DS2VASC, a patient-reported outcome, Atrial arrhythmia recurrence, and procedure or device-related complications.
The Coordinating Center will perform all data management activities for this trial. These activities include development and validation of a clinical database into which all registry data will be entered. The Coordinating Center will be responsible for ensuring overall integrity of the data and database.
Paper Case Report Forms (CRF) will be used to collect all subject data for the registry. The CRF will be developed to capture the information outlined in this protocol. Data collected on these CRFs will be entered into an electronic database by individuals at the Coordinating Center and analyzed by the registry Sponsor or participating physicians as defined in the registry protocol.
Paroxysmal Atrial Fibrillation
Catheter ablation with novel radiofrequency technologies
Alabama Cardiovascular Group
Enrolling by invitation
Heart Rhythm Clinical and Research Solutions, LLC
Published on BioPortfolio: 2019-09-18T03:27:41-0400
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