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Procedure

Ablation for Atrial Fibrillation and Heart Failure (AMPERE Trial)

N/A

Waitlist Available

Led By David Spragg, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Heart failure hospitalization lasting over 12 hours and including intravenous diuretics at a healthcare facility within 12 months prior to the enrollment visit

Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1)

Must not have

Contraindication to chronic anticoagulation therapy or heparin

Cardiac diagnosis in addition to or other than HFpEF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, and 12 months from intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of a medical procedure called pulmonary vein isolation against standard medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).

Who is the study for?

This trial is for adults aged 18-90 with heart failure symptoms treated by diuretics, documented atrial fibrillation in the last 3 months, specific echocardiographic findings of structural heart disease, and elevated BNP or NT-proBNP levels. Exclusions include life expectancy under a year, recent cardiac events or procedures, severe other conditions like pulmonary hypertension not due to HFpEF, uncontrolled thyroid issues or blood pressure, extreme obesity (BMI >65), and certain previous treatments.

What is being tested?

The study compares two approaches for managing atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction: Pulmonary Vein Isolation (a type of surgical procedure) versus standard medical management. Participants are randomly assigned to one of these treatment paths to evaluate their effectiveness.

What are the potential side effects?

While the document does not specify side effects directly related to the interventions being tested in this clinical trial, generally speaking, pulmonary vein isolation can lead to complications such as bleeding at the catheter site, damage to blood vessels or your heart's electrical system that could cause arrhythmias.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was hospitalized for heart failure and treated with IV fluids within the last year.

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I currently have symptoms of heart failure.

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My heart has structural issues found through an echo test.

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I experience sudden or ongoing irregular heartbeats.

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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take long-term blood thinners or heparin.

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I have a heart condition besides or in addition to heart failure with preserved ejection fraction.

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I currently have sepsis.

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I have a device to help my heart function or need mechanical support for my heart.

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I have fluid in my lungs not caused by heart problems.

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I have severe high blood pressure in the lungs not due to heart failure.

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I have symptoms of digoxin poisoning.

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I have had a procedure to treat atrial fibrillation in my heart.

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I am scheduled for a heart-related procedure.

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My kidney function is very low or I am on dialysis.

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My thyroid condition is not under control.

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My BMI is over 65 kg/m2.

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I had a heart problem within the last month shown by an ECG or blood test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, and 12 months from intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9, and 12 months from intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, and 12 months from intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

All-cause mortality

Change in NT pro-BNP levels

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pulmonary Vein Isolation (PVI) GroupExperimental Treatment1 Intervention

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

Group II: Medical ManagementActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pulmonary Vein Isolation

2017

N/A

~360

0 / 18Eligibility criteria met