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Hybrid Ablation Plus Medical Therapy for Persistent 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190186
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
Biotronik, Inc.
Information provided by (Responsible Party):
David Huang, University of Rochester

Brief Summary:
This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biomonitor3.

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Insertable Cardiac Monitor Not Applicable

Detailed Description:
In this study, subjects will be randomized (1:1) to conventional AF management vs. BioMonitor3®-guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), refractory to at least one antiarrhythmic agent, according to current guideline indications for persistent AF ablation and ICM (BioMonitor3®) implantation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : July 25, 2022
Estimated Study Completion Date : September 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BioMonitor3®-guided AF management
ICM obtained data will be actively used to guide and monitor treatment .
Device: Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Other Name: BioMonitor3®

No Intervention: Conventional AF Management
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).



Primary Outcome Measures :
  1. Atrial fibrillation (AF) burden defined as the mean amount of time spent in AF over a pre-specified period of time (excluding short AF episodes of ≤30 seconds) by the BioMonitor3®. [ Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) ]
    In the present study AF burden will be assessed at 3-month intervals during the 12 months following the blanking period (3-months post-ablation), and the difference at the end of the follow-up period of one year will serve as the primary comparison outcome between the two treatment groups.


Secondary Outcome Measures :
  1. Number of clinically significant (>30 min) atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia) as detected and documented by BioMonitor3® after the performance of the index AF ablation procedure. [ Time Frame: Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis). ]
  2. Number of symptomatic AF recurrence (regardless of duration). [ Time Frame: Between enrollment and 15 months. ]
  3. Number of repeat AF ablation. [ Time Frame: Between enrollment and 15 months. ]
  4. Number of cardiac hospitalization. [ Time Frame: Between enrollment and 15 months. ]
  5. Number of Deaths. [ Time Frame: Between enrollment and 15 months. ]
  6. Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits. [ Time Frame: Between enrollment and 15 months. ]
  7. Atrial Flutter or Tachycardia. [ Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) ]
    Incidence of atrial flutter or tachycardia after the index ablation procedure

  8. Incidence of repeat procedures. [ Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) ]
  9. Major adverse events requiring rehospitalization during follow-up. [ Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) ]
  10. Quality of life (QOL) as assessed by Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. [ Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) ]


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
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year), refractory to at least one antiarrhythmic agent
  • Underwent first AF ablation with successful BioMonitor3® implant before or at time of ablation

Exclusion Criteria:

  • Paroxysmal atrial fibrillation
  • Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year)
  • Permanent atrial fibrillation
  • Left atrial diameter of 60 mm or greater
  • Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment
  • Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.)
  • Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment
  • Serious known concomitant disease with a life expectancy of < 1 year
  • Pregnancy or nursing
  • Unwilling or unable to give informed consent

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): NCT04190186


Contacts
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Contact: Shelley L Secor-Socha, MS 585-275-7168 shelley.secor-socha@heart.rochester.edu
Contact: Mary Brown, MS, RN 585-275-8823 mary.brown@heart.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Mary Bourret    585-276-7089    mary__bourret@urmc.rochester.edu   
Principal Investigator: David T Huang, MD         
Sponsors and Collaborators
University of Rochester
Biotronik, Inc.
Investigators
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Principal Investigator: David Huang, MD University of Rochester
Publications:

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Responsible Party: David Huang, Professor Medicine M&D-Cardiology Div, University of Rochester
ClinicalTrials.gov Identifier: NCT04190186    
Other Study ID Numbers: 00004318
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Huang, University of Rochester:
Biotronik BioMonitor3
ICM
AF Ablation
Atrial arrhythmia
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes