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

NCT04922281 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: STUDY00005723R61HL153001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Mean amount of time spent in AF

  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).

  3-15 months (12 months)

Secondary Outcomes (4)

• Mean Healthcare utilization

  15 months

• Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)

  Baseline to 15 months

• Mean change in Functional capacity as measured by ICM

  Baseline to 15 months

• Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire

  Baseline to 15 months

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

Conventional Management

PLACEBO COMPARATOR

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).

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

Interventions

Insertable Cardiac Monitor or external non-invasive LT-ECG patch DEVICE

Implantable device that provides accurate daily transmission. 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™ 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.

Also known as: Confirm Rx™, Carnation Ambulatory Monitor ("CAM™"; Bardy Diagnostics).The CAM™ patch.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (51)

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MeSH Terms

Conditions

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

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ilan Goldenberg, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Physicians and subjects will be blinded to SCAF detected by the ICM/CIED/non-invasive LT-ECG monitor, but will be provided by the DCC upon request with full ICM/CIED/non-invasive LT-ECG monitor information on any clinical episodes. Cause-specific hospitalization and ED will be adjudicated by an independent and blinded Events Committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: February 28, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)