Ablation for Atrial Fibrillation and Heart Failure
(AMPERE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byEunice Yang, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

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).

Research Team

Eunice Yang, MD PhD

Principal Investigator

Inova Heart and Vascular Institute

Brett Atwater, MD

Principal Investigator

Inova Heart and Vascular Institute

Eligibility Criteria

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.

See 7 more

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.

See 18 more

Treatment Details

Interventions

Pulmonary Vein Isolation (Procedure)

Trial OverviewThe 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.

Participant Groups

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.