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

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ClinicalTrials.gov Identifier: NCT04922281
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ilan Goldenberg, University of Rochester

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Cardiovascular Diseases Heart Diseases Arrhythmias, Cardiac Pathologic Processes Device: Insertable Cardiac Monitor Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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-guided management (early intervention arm).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Confirm Rx™




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922281


Contacts
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Contact: Ilan Goldenberg, MD 5857335691 ilan.goldenberg@heart.rochester.edu
Contact: Mary Bourret, BA mary.bourret@heart.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Carrie Dykes, PhD    585-275-0736    carrie_dykes@urmc.rochester.edu   
Principal Investigator: David Huang, MD         
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ilan Goldenberg, MD University of Rochester
Publications:
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12.

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Responsible Party: Ilan Goldenberg, Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT04922281    
Other Study ID Numbers: STUDY00005723
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ilan Goldenberg, University of Rochester:
ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes