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Ablation Versus Medical Management of Atrial Fibrillation in HFpEF (AMPERE)

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ClinicalTrials.gov Identifier: NCT04282850
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborators:
Biosense Webster, Inc.
Medtronic
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 21, 2020
First Posted Date  ICMJE February 25, 2020
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE February 29, 2020
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
Change in AF burden as assessed by difference in percentage of time an individual is in AF [ Time Frame: 3, 6, 9, and 12 months from intervention ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • All-cause mortality [ Time Frame: 12 months ]
    All deaths within 12 months of the intervention arm.
  • Number of cardiovascular mortalities [ Time Frame: 12 months ]
    The number of deaths attributable to cardiovascular causes occurring within 12 months of the intervention arm
  • Number of all-cause hospitalizations [ Time Frame: 12 months ]
    The total number of inpatient hospitalizations within 12 months following the intervention.
  • Number of heart failure hospitalizations [ Time Frame: 12 months ]
    The total number of inpatient hospitalizations attributable to heart failure exacerbations within 12 months following the intervention.
  • Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire [ Time Frame: At enrollment (baseline) and 6 months following intervention ]
    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.
  • Change in NT pro-BNP levels [ Time Frame: At enrollment (baseline) and 6 months following intervention ]
    Serum biomarker associated with congestive heart failure symptoms, measured in (mg/ml).
  • Change in exercise capacity as assessed by the 6 minute walk distance test [ Time Frame: At baseline and 6 months post intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ablation Versus Medical Management of Atrial Fibrillation in HFpEF
Official Title  ICMJE Ablation Versus Medical Management of Atrial Fibrillation in Heart Failure With Preserved Ejection fRaction and the Effects on Exercise Capacity (AMPERE)
Brief Summary 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).
Detailed Description

Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes.

The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2:1 randomization to catheter ablation (PVI) or to medical management.
Masking: Single (Outcomes Assessor)
Masking Description:
Serum biomarkers, atrial fibrillation burden, anatomical and functional echocardiographic parameters, and exercise capacity will all be measured and analyzed by study personnel blinded to the patient's intervention.
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Heart Failure With Normal Ejection Fraction
Intervention  ICMJE Procedure: Pulmonary Vein Isolation
The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation.
Other Name: Atrial fibrillation ablation
Study Arms  ICMJE
  • Experimental: Pulmonary Vein Isolation (PVI) Group
    Subjects randomized to this treatment arm will undergo atrial fibrillation ablation, and undergo routine post-procedural follow-up.
    Intervention: Procedure: Pulmonary Vein Isolation
  • No Intervention: Medical Management
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eunice Yang, MD 410-614-8449 eyang13@jhmi.edu
Contact: Carol Tunin, PhD 410 502-1417 ctunin1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04282850
Other Study ID Numbers  ICMJE IRB00182159
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Biosense Webster, Inc.
  • Medtronic
Investigators  ICMJE
Study Chair: Hugh Calkins, MD Johns Hopkins University
Principal Investigator: David Spragg, MD Johns Hopkins University
Study Director: Kavita Sharma, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP