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

Primary Purpose

Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Insertable Cardiac Monitor

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
CHA2DS2-VASc ≥ 2 in men or ≥ 3 in women at the time of consent
CA to be performed for AF for the first time as standard of care within 1 calendar month after consent and prior to randomization date
Confirm Rx™ ICM or other FDA-approved Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 1 calendar month after consent and prior to randomization date

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 Confirm Rx™ ICM or other FDA-approved Abbott ICM device insertion
Inability to tolerate any AAD therapy
Sustained atrial fibrillation lasting more than 3 years prior to date of consent
Left atrial diameter of 60 mm or greater
Unsuccessful Confirm Rx™ ICM or other FDA-approved Abbott ICM device insertion
NYHA class IV congestive heart failure
Patients with an implantable cardiac rhythm device (ICD/CRTD/PPM)
LV ejection fraction ≤ 35% without a CIED, but indicated for an ICD/CRT-D
Coronary revascularization or valve surgery within 3 calendar months prior to date of consent
Prior valve surgery using a mechanical prosthesis anytime in past
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

Sites / Locations

University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ICM-guided Management

Conventional Management

Arm Description

Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

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).

Outcomes

Primary Outcome Measures

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 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

Mean Healthcare utilization

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)

Function capacity will be reported as peak VO2, which will be determined from CPET.

Mean change in Functional capacity as measured by ICM

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

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.

Full Information

NCT ID

NCT04922281

First Posted

June 4, 2021

Last Updated

September 5, 2023

Sponsor

University of Rochester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04922281

Brief Title

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

Acronym

ICMREDUCE-AF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 28, 2022 (Actual)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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-guided management (early intervention arm).

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Physicians and subjects will be blinded to SCAF detected by the ICM, but will be provided by the DCC upon request with full ICM information on any clinical episodes. Cause-specific hospitalization and ED will be adjudicated by an independent and blinded Events Committee.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ICM-guided Management

Arm Type

Active Comparator

Arm Description

Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Arm Title

Conventional Management

Arm Type

Placebo Comparator

Arm 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).

Intervention Type

Device

Intervention Name(s)

Insertable Cardiac Monitor

Other Intervention Name(s)

Confirm Rx™

Intervention Description

Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Primary Outcome Measure Information:

Title

Mean amount of time spent in AF

Description

Time Frame

3-15 months (12 months)

Secondary Outcome Measure Information:

Title

Mean Healthcare utilization

Description

Total number of hospitalizations for any cause, ED visits, and unplanned office visits recorded at each study follow-up visit

Time Frame

15 months

Title

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

Description

Function capacity will be reported as peak VO2, which will be determined from CPET.

Time Frame

Baseline to 15 months

Title

Mean change in Functional capacity as measured by ICM

Description

The average daily count of steps derived from the inserted cardiac monitor

Time Frame

Baseline to 15 months

Title

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

Description

Time Frame

Baseline to 15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilan Goldenberg, MD

Phone

5857335691

ilan.goldenberg@heart.rochester.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Bourret, BA

mary.bourret@heart.rochester.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilan Goldenberg, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carrie Dykes, PhD

Phone

585-275-0736

carrie_dykes@urmc.rochester.edu

First Name & Middle Initial & Last Name & Degree

David Huang, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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