Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04282850
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04282850
Study Brief:
Protocol Section:
NCT04282850