AzTrials
AzTrials

Atrial FibrillationAMPERENCT04282850

Ablation Versus Medical Management of Atrial Fibrillation in HFpEF

A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation and Heart Failure With Normal Ejection Fraction, run by Inova Health Care Services at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Pulmonary Vein Isolation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
10 Jul 2023to 26 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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)
  • Hemodynamic testing consistent with HFpEF physiology including pulmonary capillary wedge pressure (PCWP) (or LVEDP) ≥ 15 mmHg.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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
  • Severe valvular disease
  • Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemochromatosis
  • Complex congenital heart disease
  • Constrictive pericarditis
  • Severe pulmonary hypertension (RVSP > 60 mmHg), not secondary to HFpEF
  • Non-cardiac pulmonary edema
  • Clinical evidence of digoxin toxicity
  • Sepsis
  • Inability to comply with planned study procedures
  • Pregnancy or nursing mothers
  • Uncontrolled hypothyroidism or hyperthyroidism
  • BMI of >65 kg/m2

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Heart and Vascular Institute

    Fairfax, Virginia, 22031

Other trials in United States

About this study

Official title: Ablation Versus Medical Management of Atrial Fibrillation in Heart Failure With Preserved Ejection fRaction and the Effects on Exercise Capacity (AMPERE)

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).

Read the detailed description

Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes.

The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.

Being tested
Pulmonary Vein Isolation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary Vein IsolationProcedure or surgery

    Also called Atrial fibrillation ablation

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

Study groups in NCT04282850
Study groupRoleWhat they receive
Pulmonary Vein Isolation (PVI) GroupExperimentalSubjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up.
Receives: Procedure: Pulmonary Vein Isolation
Medical ManagementNo interventionSubjects randomized to this treatment arm will undergo medical management of the arrhythmia, but will not undergo invasive electrophysiologic procedures to address subject's AF.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3, 6, 9, and 12 months from intervention

Secondary outcomes (7)

  1. All-cause mortality

    All deaths within 12 months of the intervention arm.

    Measured: 12 months

  2. Number of cardiovascular mortalities

    The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm

    Measured: 12 months

  3. Number of all-cause hospitalizations

    The total number of inpatient hospitalizations within 12 months following the intervention.

    Measured: 12 months

  4. Number of heart failure hospitalizations

    The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention.

    Measured: 12 months

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

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A change of 10 points or more is considered not only clinically significant but also carries prognostic implications for event-free survival in heart failure patients.

    Measured: At enrollment (baseline) and 6 months following intervention

  6. Change in NT pro-BNP levels

    Serum biomarker associated with congestive heart failure symptoms, measured in (mg/ml).

    Measured: At enrollment (baseline) and 6 months following intervention

  7. Change in exercise capacity as assessed by the 6 minute walk distance test

    Pre-intervention arm and 6 month post-procedural exercise capacity will be assessed using change in 6 minute walk distance, defined as the total distance (in meters) traversed during 6 minutes of time. This is well-validated measure of functional capacity and prognostic marker in patients with heart failure.

    Measured: At baseline and 6 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2020
  2. Study start10 Jul 2023
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Why it stopped: enrollment was not keeping up with technology advancements. PI felt the data would not be pertinent

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2:1 randomization to catheter ablation (PVI) or to medical management.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04282850
Sponsor's protocol ID
U23-02-4965
Acronym
AMPERE
Status last verified
Mar 2026
First submitted
21 Feb 2020
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation and Heart Failure With Normal Ejection Fraction, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: enrollment was not keeping up with technology advancements. PI felt the data would not be pertinent). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AF burden as assessed by difference in percentage of time an individual is in AF (time frame: 3, 6, 9, and 12 months from intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04282850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in