Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICMREDUCE-AF)

University of Rochester

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases; Pathologic Processes

Treatments: Device: Insertable Cardiac Monitor or external non-invasive LT-ECG patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04922281

STUDY00005723

R61HL153001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• History of paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days), according to current guideline indications for paroxysmal AF CA (Class I/II); or patients with history of persistent atrial fibrillation (per 2019 HRS guidelines definition: sustained AF episode lasting more than 7 days, but less than 3 years), according to current guideline indications for persistent AF CA (Class I/IIIa) any time in the past.

• 18 years of age or older at time of consent

• CA to be performed for AF as standard of care within 2 calendar months after consent and prior to randomization date

• One of the following:

  • Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 2 calendar months after consent and prior to randomization date
  • Patients with an existing CIED (ICD/CRTD/PPM/ICM) are allowed if there is an atrial lead to track AF.
  • Patient without an existing CIED preferring to use a noninvasive LT-ECG monitor.

Exclusion criteria

• Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA)
• Inability to tolerate any AAD therapy
• Permanent atrial fibrillation lasting more than 3 years prior to date of consent
• NYHA class IV congestive heart failure
• Life expectancy <1 year after consent date for any medical condition
• Pregnancy or nursing
• Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent
• Participation in other interventional research studies (observational registries are allowed).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

ICM/CIED/non-invasive LT-ECG patch arrhythmia detection guided Management

Active Comparator group

Description:

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.

Treatment:

Device: Insertable Cardiac Monitor or external non-invasive LT-ECG patch

Conventional Management

Placebo Comparator group

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).

Treatment:

Device: Insertable Cardiac Monitor or external non-invasive LT-ECG patch