Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biotronik, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotronik ICM-guided AF management | Active Comparator | ICM obtained data will be actively used to guide and monitor treatment . |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertable Cardiac Monitor | Device | Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. |
|
| 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Huang, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Heart, PC | Ypsilanti | Michigan | 48197 | United States | ||
| Cardiology Associates Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25946280 | Background | 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. | |
| 9607453 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Biotronik ICM-guided AF Management | ICM obtained data will be actively used to guide and monitor treatment . Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Biotronik ICM-guided AF Management | ICM obtained data will be actively used to guide and monitor treatment . Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. |
| BG001 | Conventional AF Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of time spent in AF | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) |
|
15 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biotronik ICM-guided AF Management | ICM obtained data will be actively used to guide and monitor treatment . Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Huang, MD | University of Rochester | 585 275 5391 | david_huang@urmc.rochester.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2025 | Mar 7, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. | Between enrollment and 15 months. |
| Number of Participants With 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) |
| Number of Participants With Incidence of Repeat Procedures. | 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. | 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 | 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) |
| Tupelo |
| Mississippi |
| 38801 |
| United States |
| Rochester Regional Health | Rochester | New York | 14621 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| 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. |
| 27389907 | 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. |
| 27516462 | 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. |
| 25744570 | 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. |
| 26226999 | 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. |
| 29107190 | 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. |
| Withdrawal by Subject |
|
| Subject choice to explant |
|
| Physician Decision |
|
| Study was stopped |
|
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis). |
|
|
|
| Secondary | Number of Participants With Symptomatic AF Recurrence (Regardless of Duration). | Posted | Count of Participants | Participants | Between enrollment and 15 months. |
|
|
|
| Secondary | Number of Participants With Repeat AF Ablation. | Posted | Count of Participants | Participants | Between enrollment and 15 months. |
|
|
|
| Secondary | Number of Participants With Cardiac Hospitalization. | Posted | Count of Participants | Participants | Between enrollment and 15 months. |
|
|
|
| Secondary | Number of Deaths. | Posted | Count of Participants | Participants | Between enrollment and 15 months. |
|
|
|
| Secondary | Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. | Posted | Count of Participants | Participants | Between enrollment and 15 months. |
|
|
|
| Secondary | Number of Participants With Atrial Flutter or Tachycardia. | Incidence of atrial flutter or tachycardia after the index ablation procedure | Posted | Count of Participants | Participants | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) |
|
|
|
| Secondary | Number of Participants With Incidence of Repeat Procedures. | Posted | Count of Participants | Participants | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) |
|
|
|
| Secondary | Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up. | Posted | Count of Participants | Participants | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) |
|
|
|
| Secondary | Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | 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). | Posted | Mean | Standard Deviation | Score (from the AFEQT questionnaire) | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) |
|
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| 8 |
| 27 |
| EG001 | 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). | 0 | 28 | 3 | 28 | 9 | 28 |
| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Generalized Weakness | General disorders | Systematic Assessment |
|
| Pain (General) | General disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
| Cough Increased | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Generalized Weakness | General disorders | Systematic Assessment |
|
| Pain (General) | General disorders | Systematic Assessment |
|
| Pericarditis | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |