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Ablation for Atrial Fibrillation and Heart Failure (AMPERE Trial)
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).
AMPERE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAMPERE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AMPERE Trial Design
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Who is running the clinical trial?
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- 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.You are not expected to live for more than 1 year.I have a heart condition besides or in addition to heart failure with preserved ejection fraction.I currently have symptoms of heart failure.I currently have sepsis.I have had atrial fibrillation for more than 3 years.I was hospitalized for heart failure and treated with IV fluids within the last year.I have a device to help my heart function or need mechanical support for my heart.Your heart's left atrium is too big, measuring more than 6.0 cm from a specific view.I have been on diuretics for heart failure symptoms for at least 30 days.I have fluid in my lungs not caused by heart problems.My heart has structural issues found through an echo test.You have high levels of a specific protein in your blood called pro-brain natriuretic peptide or N-terminal pro b-type natriuretic peptide.My heart pumps well, with an LVEF over 50%.Your heart function tests show a certain type of heart failure with a pressure in your heart that is too high.I have not had heart surgery, angioplasty, or a stroke in the last 4 weeks.I experience sudden or ongoing irregular heartbeats.You have had documented episodes of atrial fibrillation in the last 3 months before joining the study, as shown by tests or devices.I have severe high blood pressure in the lungs not due to heart failure.I have symptoms of digoxin poisoning.I have had a procedure to treat atrial fibrillation in my heart.I am scheduled for a heart-related procedure.I am between 18 and 90 years old.My kidney function is very low or I am on dialysis.My thyroid condition is not under control.My BMI is over 65 kg/m2.I had a heart problem within the last month shown by an ECG or blood test.
- Group 1: Pulmonary Vein Isolation (PVI) Group
- Group 2: Medical Management
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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