NCT04190186Completed
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)
Source: ClinicalTrials.gov · Last updated 29 Jul 2025
Brief summary (registry, in English)
This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 20 Nov 2019
- Start date
- 25 Jun 2020
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- University of Rochester
- Diseases
- Atrial fibrillation
- NCT number
- NCT04190186
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 25 Jun 2020 to the primary completion date, 15 Feb 2024
- 4 sites 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
- Serious known concomitant disease with a life expectancy of \< 1 year
Other illness
- Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.)
- Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment
Other
- Paroxysmal atrial fibrillation
- Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year)
- Permanent atrial fibrillation
- Left atrial diameter of 60 mm or greater
- Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment
- Pregnancy or nursing
- Unwilling or unable to give informed consent
- Existing CIED such as pacemaker or ICD
Who the study is looking for
- 18 years of age or older
- History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
- Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rochester Regional Health Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Cardiology Associates Research, LLc Coordinator of this site? Confirm its status | Tupelo | United States | Unknown status |
| Michigan Heart, PC Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.