Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Arrhythmias, Cardiac
• Interventions: Device: Insertable Cardiac Monitor or external non-invasive LT-ECG patch

• Registration Number: NCT04922281
• Lead Sponsor: University of Rochester

Brief Summary

To prospectively investigate the efficacy of an insertable cardiac monitor-guided atrial fibrillation (AF) management in reducing subsequent AF burden in patients with persistent or paroxysmal AF undergoing atrial catheter ablation (CA).

Detailed Description

In this study, 120 subjects from the University of Rochester enrolling site will be randomized (1:1) to conventional AF management vs. Abbott 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 paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days) or 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 Abbott ICM implantation. The Abbott ICM incorporates a mobile app (myMerlin) that allows early detection of AF recurrence through patient-triggered remote transmissions and correlation with symptoms based on subclinical AF (SCAF) and patient-triggered remote transmissions. Future FDA-approved Abbott ICM devices using the same functionality may also be utilized in this study. This is a Phase 4 study, and we are comparing two management strategies that are currently employed in clinical practice.

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Study Start: 2022-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Management	Insertable Cardiac Monitor or external non-invasive LT-ECG patch	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).
ICM/CIED/non-invasive LT-ECG patch arrhythmia detection guided Management	Insertable Cardiac Monitor or external non-invasive LT-ECG patch	Implantable device (ICM/CIED) that provides accurate daily transmission of cardiac electrical data for arrhythmia detection. Patients without an existing CIED who prefer to use noninvasive LT-ECG monitoring will be offered to use the Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics). The CAM™ is patch approved for LT-ECG monitoring applied to the skin over the chest for a time-period of 7-days every 2 months for cardiac electrical data for arrhythmia detection.

Primary Outcome Measures

Name	Time	Method
Mean amount of time spent in AF	3-15 months (12 months)	The primary endpoint of the trial is total AF burden between 3 and 15 months after the index CA procedure (i.e. over 1-year post-blanking), as detected by an ICM which will be inserted prior to or at the time of the CA procedure, existing CIED, or non-invasive LT-ECG monitor in all study subjects. AF recurrence is defined as any episode of AF lasting \>30 seconds. AF burden will be defined as the mean amount of time spent in AF over the pre-specified period of time (excluding short AF episodes of ≤30 seconds).

Secondary Outcome Measures

Name	Time	Method
Mean change in Functional capacity as measured by ICM	Baseline to 15 months	The average daily count of steps derived from the inserted cardiac monitor
Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire	Baseline to 15 months	The AFEQT questionnaire will be used to collect quality of life data. The questionnaire has 20 questions on a 7-point Likert scale that assess symptoms, daily activities and treatment concerns. Scores range from 20-140 with higher scores indicating worse outcomes.
Mean Healthcare utilization	15 months	Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit
Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)	Baseline to 15 months	Function capacity will be reported as peak VO2, which will be determined from CPET.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States