Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation (REAL-AF)

• ClinicalTrials.gov Identifier: NCT04088071
• Recruitment Status: Recruiting
• First Posted: September 12, 2019
• Last Update Posted: February 15, 2024
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Collaborator: Biosense Webster, Inc.
• Information provided by (Responsible Party): Heart Rhythm Clinical and Research Solutions, LLC

Tracking Information

• First Submitted Date: August 26, 2019
• First Posted Date: September 12, 2019
• Last Update Posted Date: February 15, 2024
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2021)

• 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

Original Primary Outcome Measures (submitted: September 10, 2019)

• 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.

Current Secondary Outcome Measures (submitted: September 4, 2021)

• 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?

Original Secondary Outcome Measures (submitted: September 10, 2019)

• AF monitoring performed- Dual/ CRT Pacer or ICD [ Time Frame: 12 months ]
  Recurrence seen on Dual/ CRT Pacer or ICD (yes/no)
• AF monitoring performed- Event Monitor [ Time Frame: 12 months ]
  Recurrence seen on Event Monitor (yes/no)
• AF monitoring performed- LinQ [ Time Frame: 12 months ]
  Recurrence seen on LinQ (yes/no)
• AF monitoring performed- Holter [ Time Frame: 12 months ]
  Recurrence seen on Holter (yes/no)
• AF monitoring performed- EKG [ Time Frame: 12 months ]
  Recurrence seen on EKG (yes/no)
• AF monitoring performed- TTE [ Time Frame: 12 months ]
  Recurrence seen on TTE (yes/no)
• Self-reported Sleep Apnea [ Time Frame: 12 months ]
  Presence of sleep apnea and/or CPAP compliance (yes/no/suspected)
• 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?
• Procedural complications [ Time Frame: 30 days ]
  Adverse events from discharge to day 30 post-procedure
• Long-term safety [ Time Frame: 12 months ]
  Adverse events from day 31 post-procedure through the 12-month office visit date

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Real-world Experience of Catheter Ablation for the Treatment of Paroxysmal and Persistent Atrial Fibrillation
• Official Title: Real-world Experience of Catheter Ablation for the Treatment of Symptomatic ParoxysmaL and Persistent Atrial Fibrillation Using Novel CARTO Technologies: REAL AF Registry
• 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

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Study population consists of adults age 18 years or older with symptomatic Paroxysmal and Persistent Atrial Fibrillation who are candidates for ablation.

Condition

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device: Catheter ablation

Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).

Study Groups/Cohorts

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.

Intervention: Device: Catheter ablation

Publications *

• Osorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available.
• Varley AL, Kreidieh O, Godfrey BE, Whitmire C, Thorington S, D'Souza B, Kang S, Hebsur S, Ravindran BK, Zishiri E, Gidney B, Sellers MB, Singh D, Salam T, Metzl M, Ro A, Nazari J, Fisher WG, Costea A, Magnano A, Oza S, Morales G, Rajendra A, Silverstein J, Zei PC, Osorio J. A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives. J Interv Card Electrophysiol. 2021 Dec;62(3):487-494. doi: 10.1007/s10840-021-01031-w. Epub 2021 Jul 2.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2023): 15000
• Original Estimated Enrollment (submitted: September 10, 2019): 4000
• Estimated Study Completion Date: December 31, 2027
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

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'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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kim Harbin; 1-256-591-0727; kharbin@hrcrs.com

Contact: Jose Osorio, MD; josorio@hrcrs.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04088071
• Other Study ID Numbers: RAF
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Heart Rhythm Clinical and Research Solutions, LLC
• Original Responsible Party: Jose Osorio, Heart Rhythm Clinical and Research Solutions, LLC, Principal Investigator
• Current Study Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Original Study Sponsor: Jose Osorio
• Collaborators: Biosense Webster, Inc.
• Investigators: Not Provided
• PRS Account: Heart Rhythm Clinical and Research Solutions, LLC
• Verification Date: February 2024