Atrial Fibrillation Clinical Trial
— AMPEREOfficial title:
Ablation Versus Medical Management of Atrial Fibrillation in Heart Failure With Preserved Ejection fRaction and the Effects on Exercise Capacity (AMPERE)
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).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - between 18 to 90 years of age, male or female - Left Ventricular Ejection Fraction (LVEF) > 50% by echocardiogram during routine screening or within 12 months prior to enrollment day. - Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment. - Symptomatic paroxysmal or persistent atrial fibrillation. - Paroxysmal atrial fibrillation defined as recurrent AF (at least 2 episodes) that terminated spontaneously within 7 days - Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion - Included within the category of persistent AF is "long-standing persistent AF" defined as continuous AF of greater than 1 year in duration - AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter monitor, Loop recorder, memory of the implanted device, or any suitable device. - Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1) - Structural heart disease evidenced by one or both of the following echocardiographic findings (done during the transthoracic echocardiography (TTE) within 6 months of enrollment) - Left atrial enlargement (LAE) defined as LA width > 3.8 cm or LA length > 5.0 cm, or LA area > 20 cm2 or LA volume > 55 mL or LA volume index > 29 ml/m2. (of note, LA length greater than 6.0 cm will be excluded) - Left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness > 1.0 cm - And at least one of the following: - A heart failure hospitalization lasting over 12 hours and including intravenous diuretics at a healthcare facility within 12 months prior to the enrollment visit. - An elevated pro-brain natriuretic peptide (BNP) (>100 pg/mL, or N-terminal pro b-type natriuretic peptide (NT-proBNP)>300 pg/mL) - Hemodynamic testing consistent with HFpEF physiology including pulmonary capillary wedge pressure (PCWP) (or LVEDP) = 15 mmHg. Exclusion Criteria: - Previous left heart ablation procedure for AF - Contraindication to chronic anticoagulation therapy or heparin - Longstanding atrial fibrillation, defined here as greater than 3 years of persistent atrial fibrillation - Severe left atrial dilatation, with LA length > 6.0 cm, optimally from parasternal long view - Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent). - Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment. - Planned cardiovascular intervention - Listed for heart transplant - Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission - Life expectancy less than 1 year - Uncontrolled hypertension, defined as resting systolic blood pressure >190 and/or resting diastolic pressure>110 - Chronic Kidney Disease (CKD) stage 4-5 (GFR<25 ml/min/1.73m2), or on hemodialysis - Cardiac diagnosis in addition to or other than HFpEF: - Active myocarditis - Hypertrophic obstructive cardiomyopathy - Severe valvular disease - Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemochromatosis - Complex congenital heart disease - Constrictive pericarditis - Severe pulmonary hypertension (RVSP > 60 mmHg), not secondary to HFpEF - Non-cardiac pulmonary edema - Clinical evidence of digoxin toxicity - Sepsis - Inability to comply with planned study procedures - Pregnancy or nursing mothers - Uncontrolled hypothyroidism or hyperthyroidism - BMI of >65 kg/m2 |
Country | Name | City | State |
---|---|---|---|
United States | Inova Heart and Vascular Institute | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Biosense Webster, Inc., Medtronic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in AF burden as assessed by difference in percentage of time an individual is in AF | AF burden, described as the percentage of time an individual is in AF relative to the total amount of time analyzed. This outcome will be assessed at multiple intervals following intervention arm, using a continuous, implantable heart rhythm monitor. The investigators' focus will be on the change between pre-intervention AF burden and AF burden at 6 month follow-up. | 3, 6, 9, and 12 months from intervention | |
Secondary | All-cause mortality | All deaths within 12 months of the intervention arm. | 12 months | |
Secondary | Number of cardiovascular mortalities | The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm | 12 months | |
Secondary | Number of all-cause hospitalizations | The total number of inpatient hospitalizations within 12 months following the intervention. | 12 months | |
Secondary | Number of heart failure hospitalizations | The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention. | 12 months | |
Secondary | Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. A change of 10 points or more is considered not only clinically significant but also carries prognostic implications for event-free survival in heart failure patients. | At enrollment (baseline) and 6 months following intervention | |
Secondary | Change in NT pro-BNP levels | Serum biomarker associated with congestive heart failure symptoms, measured in (mg/ml). | At enrollment (baseline) and 6 months following intervention | |
Secondary | Change in exercise capacity as assessed by the 6 minute walk distance test | Pre-intervention arm and 6 month post-procedural exercise capacity will be assessed using change in 6 minute walk distance, defined as the total distance (in meters) traversed during 6 minutes of time. This is well-validated measure of functional capacity and prognostic marker in patients with heart failure. | At baseline and 6 months post intervention |
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