Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial FibrillationParoxysmal Atrial Fibrillation
- Registration Number
- NCT04088071
- Brief Summary
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation 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 and PsAF patients.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- Symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- 18 years of age or older
- De Novo ablation procedure unless it is a repeat for a patient whose index procedure is also in the registry
- Able and willing to participate in baseline and follow up evaluations for the full length of the registry
- Willing and able to provide informed consent, if applicable
- 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's duration)
- Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
- In the opinion of the investigator, any known contraindication to an ablation procedure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness at 12 months 12 months Freedom from atrial arrhythmia recurrence at 12 months post procedure.
Long-term Safety Post-procedure, 3 months, and 12 months Adverse events from post-procedure through the 12-month office visit date
Effectiveness at 90 days 90 days Freedom from atrial arrhythmia recurrence at 90 days post procedure.
- Secondary Outcome Measures
Name Time Method AF recurrence 12 months Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE
Post-procedure arrhythmia treatments 12 months Treatments for AF post-procedure
AAD Usage 12 months Antiarrhythmic drug use (and type) post procedure and 12 months
OAC usage 12 months Oral anticoagulant use at 12 months and drug type
Patient reported outcome 12 months How do you feel now compared to pre-ablation?
AF related symptoms 12 months Presence of: weakness, fluttering, SOB, fatigue, dizziness, decrease in exercise tolerance, chest pain/pressure, heart racing/palpitations, and other (yes/no)
CHA2DS2VASC 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.
Trial Locations
- Locations (65)
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
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
Scroll for more (55 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United StatesMichelle OsoinakContactWilliam Maddox, MDPrincipal Investigator