NCT04922281Active, not recruiting
Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation
Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM REDUCE-AF)
Source: ClinicalTrials.gov · Last updated 14 Oct 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Jun 2021
- Start date
- 28 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Rochester
- Diseases
- Atrial fibrillation
- NCT number
- NCT04922281
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 28 Feb 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to tolerate any AAD therapy
- Permanent atrial fibrillation lasting more than 3 years prior to date of consent
Other illness
- Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA)
- NYHA class IV congestive heart failure
- Life expectancy \<1 year after consent date for any medical condition
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.