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Registry for Real-world Experience of Catheter Ablation for Symptomatic Paroxysmal Atrial Fibrillation

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 : October 5, 2020
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Jose Osorio, Heart Rhythm Clinical and Research Solutions, LLC

Brief Summary:
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal Atrial Fibrillation (PAF) 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 patients.

Condition or disease Intervention/treatment
Paroxysmal Atrial Fibrillation Device: Catheter ablation with novel radiofrequency technologies

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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 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
RAF Cohort
Subjects with symptomatic PAF 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 with novel radiofrequency technologies
PAF 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.


Secondary Outcome Measures :
  1. AF monitoring performed- Dual/ CRT Pacer or ICD [ Time Frame: 12 months ]
    Recurrence seen on Dual/ CRT Pacer or ICD (yes/no)

  2. AF monitoring performed- Event Monitor [ Time Frame: 12 months ]
    Recurrence seen on Event Monitor (yes/no)

  3. AF monitoring performed- LinQ [ Time Frame: 12 months ]
    Recurrence seen on LinQ (yes/no)

  4. AF monitoring performed- Holter [ Time Frame: 12 months ]
    Recurrence seen on Holter (yes/no)

  5. AF monitoring performed- EKG [ Time Frame: 12 months ]
    Recurrence seen on EKG (yes/no)

  6. AF monitoring performed- TTE [ Time Frame: 12 months ]
    Recurrence seen on TTE (yes/no)

  7. Self-reported Sleep Apnea [ Time Frame: 12 months ]
    Presence of sleep apnea and/or CPAP compliance (yes/no/suspected)

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

  9. 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)

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

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

  12. 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.

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

  14. Procedural complications [ Time Frame: 30 days ]
    Adverse events from discharge to day 30 post-procedure

  15. Long-term safety [ Time Frame: 12 months ]
    Adverse events from day 31 post-procedure through the 12-month office visit date



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 Atrial Fibrillation who are candidates for ablation.
Criteria

Inclusion Criteria:

  • Subjects with symptomatic PAF who, in the opinion of the investigator, are candidates for ablation for AF.
  • Age 18 years or older.
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

  • Persistent Atrial Fibrillation (PsAF)
  • Having a repeat ablation, unless the subject's index ablation procedure is also included in the registry
  • Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry.
  • History of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran).
  • History of a documented thromboembolic event within the past 6 weeks.
  • Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
  • Diagnosed atrial myxoma.
  • Unstable angina.
  • Acute illness, active systemic infection, or sepsis.
  • Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator.
  • Current enrollment in an investigational study evaluating another device or drug.
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  • Presence of intramural thrombus, tumor, or other abnormality that precludes catheter introduction or manipulation.
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
  • Presence of a condition that precludes vascular access.

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
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United States, Alabama
Grandview Medical Center
Birmingham, Alabama, United States, 35243
United States, California
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
University HealthCare Alliance
Walnut Creek, California, United States, 94598
United States, Florida
Ascension St. Vincent's
Jacksonville, Florida, United States, 32204
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 97813
United States, Illinois
Northshore University Health System
Evanston, Illinois, United States, 60201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan Heart
Ypsilanti, Michigan, United States, 48197
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45202
Mount Carmel Columbus Cardiology Consultants
Columbus, Ohio, United States, 43213
United States, Pennsylvania
University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Upstate Cardiology
Greenville, South Carolina, United States, 29607
United States, Washington
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Jose Osorio
Biosense Webster, Inc.
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Responsible Party: Jose Osorio, Principal Investigator, 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: October 5, 2020
Last Verified: September 2020

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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