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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
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Heart Rhythm Clinical and Research Solutions, LLC

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.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Device: Catheter ablation

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. Effectiveness at 90 days [ Time Frame: 90 days ]
    Freedom from atrial arrhythmia recurrence at 90 days post procedure.

  2. Effectiveness at 12 months [ Time Frame: 12 months ]
    Freedom from atrial arrhythmia recurrence at 12 months post procedure.

  3. Long-term Safety [ Time Frame: Post-procedure, 3 months, and 12 months ]
    Adverse events from post-procedure through the 12-month office visit date


Secondary Outcome Measures :
  1. AF recurrence [ Time Frame: 12 months ]
    Recurrence seen during monitoring with Dual/ CRT Pacer or ICD; Event Monitor; LinQ; Holter; EKG; TTE

  2. Post-procedure arrhythmia treatments [ Time Frame: 12 months ]
    Treatments for AF post-procedure

  3. 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)

  4. AAD Usage [ Time Frame: 12 months ]
    Antiarrhythmic drug use (and type) post procedure and 12 months

  5. OAC usage [ Time Frame: 12 months ]
    Oral anticoagulant use at 12 months and drug type

  6. 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.

  7. Patient reported outcome [ Time Frame: 12 months ]
    How do you feel now compared to pre-ablation?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
Show Show 22 study locations
Sponsors and Collaborators
Heart Rhythm Clinical and Research Solutions, LLC
Biosense Webster, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Heart Rhythm Clinical and Research Solutions, LLC
ClinicalTrials.gov Identifier: NCT04088071    
Other Study ID Numbers: RAF
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes