Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Public ClinicalTrials.gov record NCT04160000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study To Evaluate The Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04160000
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 360 participants
Conditions and interventions
Interventions
- 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
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 25, 2020
- Primary completion
- Dec 30, 2024
- Completion
- Jun 29, 2025
- Last update posted
- May 22, 2024
2020 – 2025
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northern Arizona Health Care | Flagstaff | Arizona | 86001 | Recruiting |
| St. Bernards Heart and Vascular Center | Jonesboro | Arkansas | 72401 | Recruiting |
| South Denver Cardiology | Littleton | Colorado | 80120 | Recruiting |
| Kansas City Heart Rhythm Institute | Overland | Missouri | 66211 | Recruiting |
| Electrophysiology Research Foundation | Warren Township | New Jersey | 07059 | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| TCAI at St. David's Hospital | Austin | Texas | 78705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04160000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 22, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04160000 live on ClinicalTrials.gov.