Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

July 9, 2025 updated by: David Huang, University of Rochester

Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)

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 Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, subjects will be randomized (1:1) to conventional AF management vs. Biotronik ICM-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), according to current guideline indications for persistent AF ablation and ICM (Biotronik ICM) implantation.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart, PC
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates Research, LLC
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Rochester, New York, United States, 14621
        • Rochester Regional Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
  • Planned to undergo first AF ablation with successful Biotronik ICM 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
  • Existing CIED such as pacemaker or ICD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biotronik ICM-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 Names:
  • BioMonitor3® or future generation of Biotronik ICM
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Biotronik ICM (BioMonitor3® or Future Generation of Biotronik ICM).
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.
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Deaths.
Time Frame: Between enrollment and 15 months.
Between enrollment and 15 months.
Number of Participants With Clinically Significant (>30 Min) Atrial Arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) as Detected and Documented by Biotronik ICM 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).
Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).
Number of Participants With Symptomatic AF Recurrence (Regardless of Duration).
Time Frame: Between enrollment and 15 months.
Between enrollment and 15 months.
Number of Participants With Repeat AF Ablation.
Time Frame: Between enrollment and 15 months.
Between enrollment and 15 months.
Number of Participants With Cardiac Hospitalization.
Time Frame: Between enrollment and 15 months.
Between enrollment and 15 months.
Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits.
Time Frame: Between enrollment and 15 months.
Between enrollment and 15 months.
Number of Participants With 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
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Number of Participants With Incidence of Repeat Procedures.
Time Frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Number of Participants With 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)
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Quality of Life as Assessed by the 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)

The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire is a validated, disease-specific instrument used to assess quality of life in individuals with atrial fibrillation. It includes 20 questions across four domains: Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction.

The AFEQT provides both domain-specific scores and an overall total score. Scores for each domain and the Total Score range from 0 to 100. Higher scores indicate better quality of life, with 100 representing no symptoms or limitations and 0 representing severe symptoms or limitations. The Total Score is calculated by averaging the scores from the three core domains (Symptoms, daily activities, and treatment concern).
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Biotronik, Inc.

Investigators

  • Principal Investigator: David Huang, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00004318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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