* 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).
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.
Donnée non disponible
Inconnu
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).
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.
Conventional Management
État du recrutement
unknown
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).
Données à jour depuis :
23 juillet 2024
Description de l'étude
Description de l'étude
Résumé de l'étude
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).
Source : Importé depuis le centre
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.
