Arrhythmias, Cardiac, Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Pathologic Processes
Conditions
Keywords
ICM, Confirm Rx™ , AF Ablation, Atrial Arrhythmia
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.
Interventions
DEVICEInsertable Cardiac Monitor or external non-invasive LT-ECG patch
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean amount of time spent in AF | 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, 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Healthcare utilization | 15 months | 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) | Baseline to 15 months | Function capacity will be reported as peak VO2, which will be determined from CPET. |
| Mean change in Functional capacity as measured by ICM | Baseline to 15 months | 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 | 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. |
Countries
United States
Outcome results
None listed