Ablation Versus Medical Management of Atrial Fibrillation in HFpEF

NCT04282850 | Terminated

• 1 other identifier: U23-02-4965
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).

Conditions

Atrial Fibrillation; Heart Failure With Normal Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Change in AF burden as assessed by difference in percentage of time an individual is in AF

  AF burden, described as the percentage of time an individual is in AF relative to the total amount of time analyzed. This outcome will be assessed at multiple intervals following intervention arm, using a continuous, implantable heart rhythm monitor. The investigators' focus will be on the change between pre-intervention AF burden and AF burden at 6 month follow-up.

  3, 6, 9, and 12 months from intervention

Secondary Outcomes (7)

• All-cause mortality

  12 months

• Number of cardiovascular mortalities

  12 months

• Number of all-cause hospitalizations

  12 months

• Number of heart failure hospitalizations

  12 months

• Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire

  At enrollment (baseline) and 6 months following intervention

Study Arms (2)

Pulmonary Vein Isolation (PVI) Group

EXPERIMENTAL

Subjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up.

Procedure: Pulmonary Vein Isolation

Medical Management

NO INTERVENTION

Subjects randomized to this treatment arm will undergo medical management of the arrhythmia, but will not undergo invasive electrophysiologic procedures to address subject's AF.

Interventions

Pulmonary Vein Isolation PROCEDURE

The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation.

Also known as: Atrial fibrillation ablation

Pulmonary Vein Isolation (PVI) Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 to 90 years of age, male or female
• Left Ventricular Ejection Fraction (LVEF) \> 50% by echocardiogram during routine screening or within 12 months prior to enrollment day.
• Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment.
• Symptomatic paroxysmal or persistent atrial fibrillation.
• Paroxysmal atrial fibrillation defined as recurrent AF (at least 2 episodes) that terminated spontaneously within 7 days
• Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion
• Included within the category of persistent AF is "long-standing persistent AF" defined as continuous AF of greater than 1 year in duration
• AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter monitor, Loop recorder, memory of the implanted device, or any suitable device.
• Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1)
• Structural heart disease evidenced by one or both of the following echocardiographic findings (done during the transthoracic echocardiography (TTE) within 6 months of enrollment)
• Left atrial enlargement (LAE) defined as LA width \> 3.8 cm or LA length \> 5.0 cm, or LA area \> 20 cm2 or LA volume \> 55 mL or LA volume index \> 29 ml/m2. (of note, LA length greater than 6.0 cm will be excluded)
• Left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness \> 1.0 cm
• And at least one of the following:
• A heart failure hospitalization lasting over 12 hours and including intravenous diuretics at a healthcare facility within 12 months prior to the enrollment visit.
• An elevated pro-brain natriuretic peptide (BNP) (\>100 pg/mL, or N-terminal pro b-type natriuretic peptide (NT-proBNP)\>300 pg/mL)

You may not qualify if:

• Previous left heart ablation procedure for AF
• Contraindication to chronic anticoagulation therapy or heparin
• Longstanding atrial fibrillation, defined here as greater than 3 years of persistent atrial fibrillation
• Severe left atrial dilatation, with LA length \> 6.0 cm, optimally from parasternal long view
• Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
• Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment.
• Planned cardiovascular intervention
• Listed for heart transplant
• Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission
• Life expectancy less than 1 year
• Uncontrolled hypertension, defined as resting systolic blood pressure \>190 and/or resting diastolic pressure\>110
• Chronic Kidney Disease (CKD) stage 4-5 (GFR\<25 ml/min/1.73m2), or on hemodialysis
• Cardiac diagnosis in addition to or other than HFpEF:
• Active myocarditis
• Hypertrophic obstructive cardiomyopathy

Sponsors & Collaborators

• Inova Health Care Services: lead
• Biosense Webster, Inc.: collaborator
• Medtronic: collaborator

Study Sites (1)

Inova Heart and Vascular Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brett Atwater, MD

  Inova Heart and Vascular Institute

  STUDY CHAIR

• Eunice Yang, MD PhD

  Inova Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Serum biomarkers, atrial fibrillation burden, anatomical and functional echocardiographic parameters, and exercise capacity will all be measured and analyzed by study personnel blinded to the patient's intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2:1 randomization to catheter ablation (PVI) or to medical management.

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: July 10, 2023
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)