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NCT04160000 · ClinicalTrials.gov registry record · Phase 4

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

A Phase 4 study of Heart Failure and Atrial Fibrillation, sponsored by Electrophysiology Research Foundation.

Recruiting
Registry status
Phase 4
Development phase
360
Enrollment target
9
Study locations

NCT04160000 is a Phase 4 study of Heart Failure and Atrial Fibrillation that is actively recruiting participants, run by Electrophysiology Research Foundation. The registered enrollment target is 360 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (82% lower). The trial reports 9 study locations across 9 states.

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The verdict

NCT04160000, a Phase 4 study of Heart Failure and Atrial Fibrillation, is actively recruiting participants, sponsored by Electrophysiology Research Foundation.

RECRUITING
Registry status
Phase 4
Development phase
360 participants
Enrollment target
9
Study locations

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.

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

FieldValue
Enrollment Target 360 participants
Start Date 2020-07-26
Est. Completion 2025-06-30
Phase Phase 4

What the Registry Record Tells You About NCT04160000

The ClinicalTrials.gov registry entry for NCT04160000 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (82% lower). The listed sponsor is Electrophysiology Research Foundation, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT04160000 reports 9 study locations spanning 9 distinct geographic areas - top geographies include Arizona, Arkansas, Colorado.

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.

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).

Who is sponsoring clinical trial NCT04160000?

This trial is sponsored by Electrophysiology Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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