Using a cardiac monitor to manage atrial fibrillation after catheter ablation
Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)
This study is testing if using a special heart monitor can help people with atrial fibrillation manage their condition better after a procedure to fix it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04922281 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an insertable cardiac monitor (ICM) in managing atrial fibrillation (AF) following catheter ablation. A total of 120 participants will be randomized into two groups: one receiving conventional AF management and the other guided by the Abbott ICM. The ICM allows for early detection of AF recurrence through remote monitoring and patient-triggered transmissions. Participants will be followed for 15 months, including a 3-month blanking period post-ablation, to assess the burden of AF. The study aims to provide insights into improving AF management strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of paroxysmal or persistent atrial fibrillation scheduled for catheter ablation.
Not a fit: Patients who do not have a history of atrial fibrillation or those who are not undergoing catheter ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the burden of atrial fibrillation in patients post-ablation.
How similar studies have performed: Previous studies have shown promise in using remote monitoring for AF management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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).
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ilan Goldenberg, MD — University of Rochester
- Study coordinator: Ilan Goldenberg, MD
- Email: ilan.goldenberg@heart.rochester.edu
- Phone: 5857335691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.