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

September 5, 2023 updated by: Ilan Goldenberg, University of Rochester

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • David Huang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 1 year), 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
  • 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.

Exclusion Criteria:

  • Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA)
  • Inability or unwilling to undergo Abbott ICM device insertion
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ICM-guided Management
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Device: Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Other Names:
  • Confirm Rx™
Placebo Comparator: Conventional 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).
Device: Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Other Names:
  • Confirm Rx™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean amount of time spent in AF
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Healthcare utilization
Time Frame: 15 months
Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit
15 months
Mean change in Functional capacity as measured by Cardiopulmonary Exercise Test (CPET)
Time Frame: Baseline to 15 months
Function capacity will be reported as peak VO2, which will be determined from CPET.
Baseline to 15 months
Mean change in Functional capacity as measured by ICM
Time Frame: Baseline to 15 months
The average daily count of steps derived from the inserted cardiac monitor
Baseline to 15 months
Mean change in Quality of life using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Time Frame: 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.
Baseline to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ilan Goldenberg, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005723
  • R61HL153001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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