Clinical trial NCT04922281: Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation
Official title: Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes
Keywords: ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study population will include 120 subjects with history of paroxysmal or persistent AF who have been referred for a CA procedure based on conventional clinical indications and who will be randomized 1:1 to conventional (control arm) or ICM/CIED/non-invasive LT-ECG monitor-guided management (early intervention arm).
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Mean amount of time spent in AF
timeFrame: 3-15 months (12 months)
Secondary outcomes:
measure: Mean Healthcare utilization
timeFrame: 15 months
measure: Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)
timeFrame: Baseline to 15 months
measure: Mean change in Functional capacity as measured by ICM
timeFrame: Baseline to 15 months
measure: Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
timeFrame: Baseline to 15 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Ilan Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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