RecruitingPhase 4NCT04160000

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

A Phase 4, Randomized, Open Label, Multicenter Prospective Comparative Study To Evaluate The Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure


Sponsor

Electrophysiology Research Foundation

Enrollment

360 participants

Start Date

Jul 26, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether treating atrial fibrillation (an irregular heartbeat) with catheter ablation — a procedure that uses energy to destroy the heart tissue causing abnormal signals — can help patients who also have heart failure with preserved ejection fraction (HFpEF, meaning the heart pumps normally but doesn't fill properly). Both conditions often occur together and worsen each other. **You may be eligible if...** - You are 50 or older (men and post-menopausal women, or pre-menopausal women on continuous birth control) - You have symptomatic heart failure AND paroxysmal or persistent atrial fibrillation - You have required diuretics (water pills) for at least 30 days, or have been hospitalized for heart failure or AF in the past 12 months - You have elevated NT-proBNP levels (a marker of heart strain) **You may NOT be eligible if...** - You have a different type of heart failure (not the preserved ejection fraction type) - You do not have documented atrial fibrillation alongside your heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECatheter ablation

Delivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature

DRUGRate or Rhythm control antiarrhythmic drugs for atrial fibrillation

Administration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation

DEVICEInsertion of CardioMems Hemodynamic monitor

Insertion of wireless hemodynamic monitor to provide hemodynamic data to guide heart failure therapy to achieve heart failure improvement.

DRUGEmpiric heart failure drug therapy

Administration of heart failure drug therapy based on clinical evaluation to achieve heart failure improvement.


Locations(9)

Northern Arizona Health Care

Flagstaff, Arizona, United States

St. Bernards Heart and Vascular Center

Jonesboro, Arkansas, United States

South Denver Cardiology

Littleton, Colorado, United States

Kansas City Heart Rhythm Institute

Overland, Missouri, United States

Electrophysiology Research Foundation

Warren Township, New Jersey, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

TCAI at St. David's Hospital

Austin, Texas, United States

Peter Osypka Herzzentrum

Munich, Bavaria, Germany

Hopitaux Universitaires de Geneve

Geneva, Canton of Geneva, Switzerland

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NCT04160000


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