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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088071
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2019
Last Update Posted : January 13, 2022
Sponsor:
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 January 13, 2022
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date March 30, 2024   (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.
Change History
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 Contact Force 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: January 12, 2022)
8000
Original Estimated Enrollment
 (submitted: September 10, 2019)
4000
Estimated Study Completion Date December 31, 2024
Estimated Primary Completion Date March 30, 2024   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
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 January 2022