Atrial Fibrillation Treatment in Heart Failure with Preserved Function
This study is for people aged 18 to 75 with atrial fibrillation (an irregular heartbeat) and a type of heart failure called heart failure with preserved cardiac function. Researchers are comparing two ways to manage atrial fibrillation: catheter ablation (a procedure to correct the heart's electrical signals) or antiarrhythmic drugs (medications to control heart rhythm). The study also looks at whether adding a CardioMems Hemodynamic monitor (a device to track heart function) helps guide heart failure treatment. The main goal is to see which approach best reduces hospitalizations for heart failure or death from heart problems over 12 months. You must be willing to give informed consent and be an outpatient at least 50 years old (or a post-menopausal female, or a premenopausal female on continuous birth control).
- Study design
- This is an open-label, two-phase study where 100 participants will be randomly assigned to either catheter ablation or antiarrhythmic drug therapy.
- What's involved
- Participants will be followed for at least 6 months after a 3-month initial period. Some participants will also have a CardioMems monitor inserted.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months to track heart failure hospitalizations or cardiovascular mortality.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
At a glance
Conditions
NCT04160000
Where you'd take part
This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Electrophysiology Research Foundation
Warren Township, New Jerseystudy coordinator listed
Recruiting
Hopitaux Universitaires de Geneve
Geneva, Canton of Geneva, Switzerlandstudy coordinator listed
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Kansas City Heart Rhythm Institute
Overland, Missouristudy coordinator listed
Recruiting
Northern Arizona Health Care
Flagstaff, Arizonastudy coordinator listed
Recruiting
Peter Osypka Herzzentrum
Munich, Bavaria, Germanystudy coordinator listed
Not yet recruiting
South Denver Cardiology
Littleton, Coloradostudy coordinator listed
Recruiting
St. Bernards Heart and Vascular Center
Jonesboro, Arkansasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sanjeev Saksena, MD · STUDY_CHAIR · Electrophysiology Research Foundation
- Andrea Natale, MD · STUDY_DIRECTOR · Electrophysiology Research Foundation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Time to Composite of Heart failure hospitalizations and/or Cardiovascular mortalityFrom date of randomization until the date of first documented heart failure hospitalization or date of death from cardiovascular causes, whichever came first, assessed up to 12 months
Time to either first of Heart failure hospitalization and/or mortality due to cardiovascular etiology