Ablation for Atrial Fibrillation and Heart Failure

(AMPERE Trial)

Recruiting at 1 trial location

Overseen By Tracy Plummer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Diuretics

Must not be taking: Anticoagulants, Heparin

Disqualifiers: CKD stage 4-5, Severe valvular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Brett Atwater, MD

Principal Investigator

Inova Heart and Vascular Institute

Eunice Yang, MD PhD

Principal Investigator

Inova Heart and Vascular Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I currently have symptoms of heart failure.

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

I have been on diuretics for heart failure symptoms for at least 30 days.

Exclusion Criteria

I cannot take long-term blood thinners or heparin.

Your blood pressure is very high, even when you are resting.

You are on the waiting list for a heart transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either pulmonary vein isolation (PVI) or medical management for atrial fibrillation

6 months

Routine post-procedural follow-up visits

Follow-up

Participants are monitored for changes in quality of life, NT pro-BNP levels, exercise capacity, and AF burden

12 months

Multiple follow-up assessments at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Vein Isolation

Trial Overview 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.

How Is the Trial Designed?

Group I: Pulmonary Vein Isolation (PVI) Group Experimental Treatment 1 Intervention

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

Group II: Medical Management Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Biosense Webster, Inc.

Industry Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc