Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

NCT04190186 | Completed Results DMC FDA Device

• 1 other identifier: 00004318
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

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

Conditions

Persistent Atrial Fibrillation

Keywords

Biotronik BioMonitor; ICM; AF Ablation; Atrial arrhythmia

Outcome Measures

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).

  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 Outcomes (10)

• 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.

  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).

  Between enrollment and 15 months.

• Number of Participants With Repeat AF Ablation.

  Between enrollment and 15 months.

• Number of Participants With Cardiac Hospitalization.

  Between enrollment and 15 months.

• Number of Deaths.

  Between enrollment and 15 months.

Study Arms (2)

Biotronik ICM-guided AF management

ACTIVE COMPARATOR

ICM obtained data will be actively used to guide and monitor treatment .

Device: Insertable Cardiac Monitor

Conventional AF Management

NO INTERVENTION

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).

Interventions

Insertable Cardiac Monitor DEVICE

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

Also known as: BioMonitor3® or future generation of Biotronik ICM

Biotronik ICM-guided AF management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Biotronik, Inc.: collaborator

Study Sites (4)

Michigan Heart, PC

Ypsilanti, Michigan, 48197, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Rochester Regional Health

Rochester, New York, 14621, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (7)

• Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 BACKGROUND

• Huang DT, Monahan KM, Zimetbaum P, Papageorgiou P, Epstein LM, Josephson ME. Hybrid pharmacologic and ablative therapy: a novel and effective approach for the management of atrial fibrillation. J Cardiovasc Electrophysiol. 1998 May;9(5):462-9. doi: 10.1111/j.1540-8167.1998.tb01837.x.

  PMID: 9607453 BACKGROUND

• Kirchhof P, Calkins H. Catheter ablation in patients with persistent atrial fibrillation. Eur Heart J. 2017 Jan 1;38(1):20-26. doi: 10.1093/eurheartj/ehw260. Epub 2016 Jul 7.

  PMID: 27389907 BACKGROUND

• Willems S, Khairy P, Andrade JG, Hoffmann BA, Levesque S, Verma A, Weerasooriya R, Novak P, Arentz T, Deisenhofer I, Rostock T, Steven D, Rivard L, Guerra PG, Dyrda K, Mondesert B, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S, Macle L; ADVICE Trial Investigators*. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e003909. doi: 10.1161/CIRCEP.115.003909.

  PMID: 27516462 BACKGROUND

• Schreiber D, Rostock T, Frohlich M, Sultan A, Servatius H, Hoffmann BA, Luker J, Berner I, Schaffer B, Wegscheider K, Lezius S, Willems S, Steven D. Five-year follow-up after catheter ablation of persistent atrial fibrillation using the stepwise approach and prognostic factors for success. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):308-17. doi: 10.1161/CIRCEP.114.001672. Epub 2015 Mar 5.

  PMID: 25744570 BACKGROUND

• Reiffel JA, Camm AJ, Belardinelli L, Zeng D, Karwatowska-Prokopczuk E, Olmsted A, Zareba W, Rosero S, Kowey P; HARMONY Investigators. The HARMONY Trial: Combined Ranolazine and Dronedarone in the Management of Paroxysmal Atrial Fibrillation: Mechanistic and Therapeutic Synergism. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1048-56. doi: 10.1161/CIRCEP.115.002856. Epub 2015 Jul 30.

  PMID: 26226999 BACKGROUND

• Tondo C, Iacopino S, Pieragnoli P, Molon G, Verlato R, Curnis A, Landolina M, Allocca G, Arena G, Fassini G, Sciarra L, Luzi M, Manfrin M, Padeletti L; ClinicalService 1STOP Project Investigators. Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Heart Rhythm. 2018 Mar;15(3):363-368. doi: 10.1016/j.hrthm.2017.10.038. Epub 2017 Oct 26.

  PMID: 29107190 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Huang, MD
• Organization: University of Rochester

david_huang@urmc.rochester.edu

585 275 5391

Study Officials

• David Huang, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Medicine M&D-Cardiology Div

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 9, 2019
• Study Start: June 25, 2020
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)