Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation (REAL-AF)
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|ClinicalTrials.gov Identifier: NCT04088071|
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2019
Last Update Posted : September 13, 2021
|Condition or disease||Intervention/treatment|
|Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation||Device: Catheter ablation|
The REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF). Future new contact force technologies may be included as they become available in the market. Patient assessments will occur at the following time points: 1) pre-ablation, 2) procedure, 3) 10-12 weeks, 4) 6 months (monitor only) and 5) 1 year post ablation.
The objective of this registry is to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of RF ablations in the treatment of patients with Paroxysmal or Persistent atrial fibrillation. The outcomes of the registry are: 1) long term effectiveness defined as freedom from atrial arrhythmia recurrence post 90 day blanking period, and 2) acute and late onset complications.
Sites selected for this registry will already have the following pre and post procedure assessments as part of their standard of care:
Patient assessments at the following time points: (1) pre-ablation or baseline, (2) procedure, (3) 10-12 weeks, (4) 6 months (monitor only) and (5) 1 year post ablation.
Pre ablation/baseline assessment should include: TTE (within 6 months of procedure), CHADS2Vasc, sleep apnea, AAD status, OAC, Medical and Arrhythmia History 10-12 Week Follow-Up Office Visit: Physician evaluation, AAD status, OAC usage, repeat TTE, and Arrhythmia Reoccurrence and Treatment Assessment Monitoring: 96-hour continuous heart rhythm monitor scheduled at 6 months and 12 months post ablation, with an event monitor ordered as needed for symptomatic arrhythmias.
12 Month Follow up Office Visit: Physician evaluation, AF Type, AF Monitoring method, Sleep apnea, Post-procedure arrhythmia treatments, AF related symptoms and QOL improvement, AAD and OAC usage, CHA2DS2VASC and Arrhythmia Reoccurrence and Treatment Assessment
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||4000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation Using Novel Contact Force Technologies: REAL AF Registry|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Patients with atrial fibrillation
Subjects with symptomatic PAF or PsAF who, in the opinion of the investigator, are candidates for ablation for AF, age 18 years or older, and are able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Device: Catheter ablation
Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
- Effectiveness at 90 days [ Time Frame: 90 days ]Freedom from atrial arrhythmia recurrence at 90 days post procedure.
- Effectiveness at 12 months [ Time Frame: 12 months ]Freedom from atrial arrhythmia recurrence at 12 months post procedure.
- Long-term Safety [ Time Frame: Post-procedure, 3 months, and 12 months ]Adverse events from post-procedure through the 12-month office visit date
- AF recurrence [ Time Frame: 12 months ]Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
- Post-procedure arrhythmia treatments [ Time Frame: 12 months ]Treatments for AF post-procedure
- AF related symptoms [ Time Frame: 12 months ]Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)
- AAD Usage [ Time Frame: 12 months ]Antiarrhythmic drug use (and type) post procedure and 12 months
- OAC usage [ Time Frame: 12 months ]Oral anticoagulant use at 12 months and drug type
- CHA2DS2VASC [ Time Frame: 12 months ]An estimation of stroke risk for patients with Atrial Fibrillation. Composite score of: Age (<65= 0; 65-74=1; >75=2) + Sex (Female=1; Male=0) + Congestive Heart Failure (Yes =1; No=0) + Hypertension (Yes= 1; No= 0) + Stroke, Transient Ischemic Attack (TIA) or thromboembolism (Yes=2; No=0) + Vascular Disease (Yes=1; No=0) + Diabetes (Yes=1; No=0). Scores range from 0 to 9, with higher scores indicating greater risk for stroke.
- Patient reported outcome [ Time Frame: 12 months ]How do you feel now compared to pre-ablation?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088071