Skip to main content
OpenTrials
Completed

NCT Number: NCT04190186

Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Heart, PC, Ypsilanti, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insertable cardiac monitor

Device

Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Other names: BioMonitor3® or future generation of Biotronik ICM

Primary outcomes

  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 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.

Secondary outcomes

  1. 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).

  2. Number of Participants With Symptomatic AF Recurrence (Regardless of Duration).

    Time frame: Between enrollment and 15 months.

  3. Number of Participants With Repeat AF Ablation.

    Time frame: Between enrollment and 15 months.

  4. Number of Participants With Cardiac Hospitalization.

    Time frame: Between enrollment and 15 months.

  5. Number of Deaths.

    Time frame: Between enrollment and 15 months.

  6. 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.

  7. 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

  8. 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)

  9. 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)

  10. 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).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Biotronik, Inc.

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.