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Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Primary Purpose

Persistent Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Insertable Cardiac Monitor

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Biotronik BioMonitor, ICM, AF Ablation, Atrial arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Michigan Heart, PCRecruiting
Cardiology Associates Research, LLCRecruiting
Rochester Regional HealthRecruiting
University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Biotronik ICM-guided AF management

Conventional AF Management

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of symptomatic AF recurrence (regardless of duration).

Number of repeat AF ablation.

Number of cardiac hospitalization.

Number of Deaths.

Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.

Atrial Flutter or Tachycardia.

Incidence of atrial flutter or tachycardia after the index ablation procedure

Incidence of repeat procedures.

Major adverse events requiring rehospitalization during follow-up.

Quality of life (QOL) as assessed by Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire.

Full Information

NCT ID

NCT04190186

First Posted

November 20, 2019

Last Updated

January 4, 2023

Sponsor

University of Rochester

Collaborators

Biotronik, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04190186

Brief Title

Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 25, 2020 (Actual)

Primary Completion Date

August 26, 2024 (Anticipated)

Study Completion Date

October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Biotronik, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Atrial Fibrillation

Keywords

Biotronik BioMonitor, ICM, AF Ablation, Atrial arrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biotronik ICM-guided AF management

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conventional AF Management

Arm Type

No Intervention

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Insertable Cardiac Monitor

Other Intervention Name(s)

BioMonitor3® or future generation of Biotronik ICM

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)

Secondary Outcome Measure Information:

Title

Time Frame

Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).

Title

Number of symptomatic AF recurrence (regardless of duration).

Time Frame

Between enrollment and 15 months.

Title

Number of repeat AF ablation.

Time Frame

Between enrollment and 15 months.

Title

Number of cardiac hospitalization.

Time Frame

Between enrollment and 15 months.

Title

Number of Deaths.

Time Frame

Between enrollment and 15 months.

Title

Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.

Time Frame

Between enrollment and 15 months.

Title

Atrial Flutter or Tachycardia.

Description

Incidence of atrial flutter or tachycardia after the index ablation procedure

Time Frame

Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)

Title

Incidence of repeat procedures.

Time Frame

Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)

Title

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)

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary C Bourret, BA

Phone

585-275-3445

mary.bourret@heart.rochester.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Brown, MS, RN

Phone

585-275-8823

mary.brown@heart.rochester.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Huang, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Michigan Heart, PC

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nora Marchelletta, RN

Phone

734-712-8621

nmarchelletta@michiganheart.com

First Name & Middle Initial & Last Name & Degree

Shrinivas Hebsur, MD

Facility Name

Cardiology Associates Research, LLC

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yvonne Ray

Phone

662-377-5447

yray@nmhs.net

First Name & Middle Initial & Last Name & Degree

James Stone, MD

Facility Name

Rochester Regional Health

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Megan Littleton, RN

Phone

585-922-3536

megan.littleton@rochesterregional.org

First Name & Middle Initial & Last Name & Degree

Jennifer LaLonde

Phone

585-922-3536

Jennifer.LaLonde@rochesterregional.org

First Name & Middle Initial & Last Name & Degree

Mohan Rao, MD

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Solomiya Rachynska

Phone

585-273-1300

solomiya__rachynska@urmc.rochester.edu

First Name & Middle Initial & Last Name & Degree

David T Huang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25946280

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.

Results Reference

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PubMed Identifier

9607453

Citation

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.

Results Reference

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PubMed Identifier

27389907

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.

Results Reference

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PubMed Identifier

27516462

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.

Results Reference

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PubMed Identifier

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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.

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PubMed Identifier

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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.

Results Reference

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PubMed Identifier

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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.

Results Reference

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Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

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