Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190186
• Other study ID #: 00004318
• Status: Completed
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Locations

Country	Name	City	State
United States	Rochester Regional Health	Rochester	New York
United States	University of Rochester	Rochester	New York
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	Michigan Heart, PC	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Biotronik, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of 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).
Secondary	Number of symptomatic AF recurrence (regardless of duration).		Between enrollment and 15 months.
Secondary	Number of repeat AF ablation.		Between enrollment and 15 months.
Secondary	Number of cardiac hospitalization.		Between enrollment and 15 months.
Secondary	Number of Deaths.		Between enrollment and 15 months.
Secondary	Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.		Between enrollment and 15 months.
Secondary	Atrial Flutter or Tachycardia.	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)
Secondary	Incidence of repeat procedures.		Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Secondary	Major adverse events requiring rehospitalization during follow-up.		Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Secondary	Quality of life (QOL) as assessed by Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire.		Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)