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Procedure

Ablation for Atrial Fibrillation and Heart Failure (AMPERE Trial)

N/A
Waitlist Available
Led By Eunice Yang, MD PhD
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
Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, and 12 months from intervention
Awards & highlights

AMPERE Trial 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.Check my eligibility
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.See study design
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.

AMPERE Trial 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 have been on diuretics for heart failure symptoms for at least 30 days.
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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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My heart pumps well, with an LVEF over 50%.
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I experience sudden or ongoing irregular heartbeats.
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I am between 18 and 90 years old.

AMPERE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in AF burden as assessed by difference in percentage of time an individual is in AF
Secondary outcome measures
All-cause mortality
Change in NT pro-BNP levels
Change in exercise capacity as assessed by the 6 minute walk distance test
+4 more

AMPERE 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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,577 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
7,589 Patients Enrolled for Atrial Fibrillation
Biosense Webster, Inc.Industry Sponsor
121 Previous Clinical Trials
37,579 Total Patients Enrolled
80 Trials studying Atrial Fibrillation
28,194 Patients Enrolled for Atrial Fibrillation
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,251 Total Patients Enrolled
64 Trials studying Atrial Fibrillation
19,211 Patients Enrolled for Atrial Fibrillation

Media Library

Pulmonary Vein Isolation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04282850 — N/A
Atrial Fibrillation Research Study Groups: Pulmonary Vein Isolation (PVI) Group, Medical Management
Atrial Fibrillation Clinical Trial 2023: Pulmonary Vein Isolation Highlights & Side Effects. Trial Name: NCT04282850 — N/A
Pulmonary Vein Isolation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282850 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be likely to qualify as a participant in this clinical experiment?

"Candidates between the ages of 18 and 90 that display atrial fibrillation may be considered for this medical trial. The target recruitment is 60 individuals in total."

Answered by AI

What is the highest possible number of participants that can join this experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this trial, which was first posted on February 29th 2020, is actively searching for participants. The study requires 60 patients to be recruited from 1 medical centre."

Answered by AI

Does the age range of participants in this clinical trial extend to octogenarians?

"This clinical trial mandates that enrollees are between the ages of 18 and 90. There are 1140 studies available for those older than 65, and 33 specifically designed for individuals younger than eighteen years old."

Answered by AI

Is entry into this investigation currently accessible for participants?

"Affirmative. According to the details published on clinicaltrials.gov, this trial was first made public on February 29th 2020 and is still actively recruiting patients with an aim of enrolling 60 individuals at one testing centre."

Answered by AI
~32 spots leftby Jan 2025