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Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
NCT04160000 · View on ClinicalTrials.gov ↗
Study Summary
Heart failure (HF) with preserved left ventricular function (pEF) is difficult clinical syndrome to treat effectively with few evidence based therapies. Atrial fibrillation (AF) is now an important co-morbidity being observed in 43% of patients with HFpEF. Rhythm control has not been studied in this population. Catheter ablation and antiarrhythmic drugs are rhythm control therapies that have been used for treatment of AF without HF or HF with reduced systolic function but have not been widely applied in HFpEF. No controlled comparative evaluation has been performed in HFpEF. The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF. Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF. In this study, we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design.
Conditions Studied
Interventions
- DEVICE Catheter ablation
- DRUG Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation
- DEVICE Insertion of CardioMems Hemodynamic monitor
- DRUG Empiric heart failure drug therapy
Study Locations (9)
Arizona
- Northern Arizona Health Care — Flagstaff
Arkansas
- St. Bernards Heart and Vascular Center — Jonesboro
Colorado
- South Denver Cardiology — Littleton
Missouri
- Kansas City Heart Rhythm Institute — Overland
New Jersey
- Electrophysiology Research Foundation — Warren Township
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
Texas
- TCAI at St. David's Hospital — Austin
Bavaria
- Peter Osypka Herzzentrum — Munich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2020-07-26 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04160000
The ClinicalTrials.gov registry entry for NCT04160000 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Electrophysiology Research Foundation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 4 interventions — of which Catheter ablation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04160000 reports 9 study locations spanning 9 distinct geographic areas — top geographies include Arizona, Arkansas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04160000 about?
NCT04160000 is a clinical study titled "Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure". Heart failure (HF) with preserved left ventricular function (pEF) is difficult clinical syndrome to treat effectively with few evidence based therapies. Atrial fibrillation (AF) is now an important co-morbidity being observed in 43% of patients with HFpEF. Rhythm control has not been studied in this...
What is the current status of trial NCT04160000?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 360 participants. The study started on 2020-07-26. Estimated completion is 2025-06-30.
What conditions does trial NCT04160000 study?
This clinical trial studies the following conditions: Heart Failure, Atrial Fibrillation, Diastolic Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04160000?
The interventions under investigation include: Catheter ablation (DEVICE), Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation (DRUG), Insertion of CardioMems Hemodynamic monitor (DEVICE), Empiric heart failure drug therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04160000?
This trial is sponsored by Electrophysiology Research Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04160000 being conducted?
This trial has 9 study locations across Arizona, Arkansas, Colorado, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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