Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

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

• Atrial Fibrillation
• Heart Failure
• Diastolic Heart Failure

Interventions

DEVICE

Catheter 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

DRUG

Rate 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

DEVICE

Insertion of CardioMems Hemodynamic monitor

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

DRUG

Empiric heart failure drug therapy

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

Sponsors & Collaborators

• Electrophysiology Research Foundation

  lead OTHER

Principal Investigators

• Sanjeev Saksena, MD · Electrophysiology Research Foundation

• Andrea Natale, MD · Electrophysiology Research Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-26

Primary Completion

2024-12-31

Completion

2025-06-30

FDA Drug

Yes

FDA Device

Yes

Countries

• United States
• Germany
• Switzerland

Study Locations