Ablation for Atrial Fibrillation and Heart Failure
(AMPERE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether a heart procedure called pulmonary vein isolation (PVI) is more effective than standard medications for treating atrial fibrillation in individuals with heart failure with preserved ejection fraction (HFpEF). Participants will be divided into two groups: one will undergo the PVI procedure, while the other will continue with standard medical management. Ideal candidates for this trial are those experiencing heart failure symptoms and dealing with recurrent or ongoing atrial fibrillation. As an unphased trial, this study provides participants the chance to contribute to important research that could enhance treatment options for heart conditions.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that pulmonary vein isolation is safe for atrial fibrillation in patients with heart failure?
Research has shown that pulmonary vein isolation (PVI), a treatment for atrial fibrillation (AF), is generally safe. In a large study involving over 18,000 patients, PVI achieved a long-term success rate of about 43% for treating non-paroxysmal AF, indicating effectiveness for less than half of the patients over time. Regarding safety, another study found that 2.3% of patients experienced major safety issues, including serious but rare events like inflammation of the heart lining (pericarditis) and heart attacks.
Over the past 30 years, PVI has been recognized as a safe and effective treatment for AF. While risks exist, they are generally low, and many patients handle the procedure well. However, understanding the potential risks and discussing them with a doctor is important.12345Why are researchers excited about this trial?
Researchers are excited about Pulmonary Vein Isolation (PVI) for atrial fibrillation and heart failure because it offers a unique approach compared to traditional medical management. While standard treatments often rely on medication to control heart rhythm, PVI directly targets the areas in the heart that trigger irregular beats by isolating the pulmonary veins. This technique aims to provide a more permanent solution by addressing the root cause of atrial fibrillation, potentially reducing symptoms and improving heart function. By focusing on the precise source of the arrhythmia, PVI has the potential to offer a more effective and long-lasting outcome for patients.
What evidence suggests that pulmonary vein isolation might be an effective treatment for atrial fibrillation in patients with heart failure?
Research shows that pulmonary vein isolation (PVI), a procedure participants in this trial may receive, can reduce episodes of atrial fibrillation (AF), a type of irregular heartbeat. Studies have found that PVI significantly lowers the chances of AF recurrence and reduces hospital visits due to irregular heartbeats. One study found that PVI was 63.5% effective one year after the procedure. Additionally, patients with heart failure and normal heart pumping function (HFpEF) experienced fewer hospital visits for heart failure soon after undergoing PVI. These findings suggest that PVI might help manage AF symptoms in patients with HFpEF.24678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either pulmonary vein isolation (PVI) or medical management for atrial fibrillation
Follow-up
Participants are monitored for changes in quality of life, NT pro-BNP levels, exercise capacity, and AF burden
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?
2
Treatment groups
Experimental Treatment
Active Control
Subjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Biosense Webster, Inc.
Industry Sponsor
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
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
Citations
Comparing outcomes after pulmonary vein isolation in ...
Reductions in HF and arrhythmia hospitalizations are observed early after PVI across all patients with HF, but patients with HFpEF demonstrate higher HF ...
Pulsed Field Ablation for Persistent Atrial Fibrillation
Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...
Five-Year Outcomes after Segmental Pulmonary Vein ...
Overall five-year outcomes after PVI for PAF are consistent with previously reported shorter term follow-up (≤2 years); however, late recurrences (>2 years) ...
4.
ahajournals.org
ahajournals.org/doi/10.1161/circ.150.suppl_1.4139264?doi=10.1161/circ.150.suppl_1.4139264Abstract 4139264: Outcomes Of Pulmonary Vein Isolation ...
Our analysis revealed a significant improvement in AF recurrence for the cryoablation technique with PVI+PWI (RR=0.56, 95% CI: 0.41, 0.76, I2=0% ...
Outcomes of Atrial Fibrillation Ablation Among Older Adults ...
The purpose of this study was to evaluate patient characteristics, population rates, and 30-day outcomes of PVI in a nationwide sample of US adults aged >65 ...
Acute and long-term outcomes of pulmonary vein isolation ...
A meta-analysis involving 18,657 patients with non-paroxysmal AF showed that the long-term success rate of a single PVI was only 43% (3). Various combined ...
2024 European Heart Rhythm Association ... - Oxford Academic
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the ...
Effect of Catheter Ablation Using Pulmonary Vein Isolation ...
Meta-analyses had reported a single procedure success for catheter ablation for persistent AF ranging from 43% to 67%. In an attempt to improve ...
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