Phase
Condition
Chest Pain
Dysrhythmia
Congestive Heart Failure
Treatment
Empiric heart failure drug therapy
Insertion of CardioMems Hemodynamic monitor
Catheter ablation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patient with symptomatic Heart Failure with preserved systolic cardiac function & paroxysmal or persistent atrial fibrillation who meet the following criteria
Subjects must be willing and able to give written informed consent
Outpatients ≥ 50 years of age, male or post- menopausal female patients;premenopausal female patients who are on and will maintain continuous birth controltherapy during the study.
Subjects must have documented HFpEF & paroxysmal or persistent AF and satisfy one ofthe following inclusion criteria a) Consecutive patients with AF, symptomatic heartfailure requiring diuretic therapy for at least 30 days prior to study entry b)Hospitalization for HF and/or AF in the past 12 months prior to catheter ablationwith documented NT-pro BNP >200pg/ml for patients not in AF or > 600 pg/ml forpatients in AF on screening ECG or NYHA class 2, 3 or ambulatory class 4 heartfailure documented NT-pro BNP >300pg/ml for patients not in AF or > 900 pg/ml forpatients in AF on screening ECG c).Evidence of structural heart disease defined asby at least 1 of the following echocardiography findings (any local measurement madeduring the screening epoch or within the 6 months prior to screening visit): 1) LAenlargement defined by at least 1 of the following: LA width (diameter) >3.8 cm orLA length >5.0 cm or LA area >20 cm2 or LA volume >55 ml or LA volume index >29ml/m2 2) LVH defined by septal thickness or posterior wall thickness >1.1 cm d).Leftventricular ejection fraction > 45% using standard imaging techniques at enrollmentfor study or in prior 6 months e).ECG documented paroxysmal or persistent atrialfibrillation f).Patients are candidates for a clinically indicated catheter ablationprocedure, and Rate or Rhythm control antiarrhythmic drug therapy
Patients should be on one or more standard heart failure drug therapy (ies) forheart failure with preserved cardiac function for at least 30 days
Written informed consent for the clinically indicated study procedures
Patients must be candidates for long-term OAC therapy based on clinical practiceguidelines for treatment of AF. Guidelines for GFR as established for DOACSs will beapplicable to all subjects.
Exclusion
Exclusion Criteria:
Patients with HFpEF who were not on any drug therapy for HF or have uncontrolledhypertension defined as systolic BP >180 mm Hg at screening or >150 mm Hg on threeor more antihypertensive drugs
Patients with QRS duration of >120 ms and intraventricular conduction defects whoare or maybe candidates for or have received ventricular resynchronization therapy
Recent (<1 month) myocardial infarction or acute coronary syndrome
Recent (<3 months) coronary revascularization procedures
Documented LA thrombus on TEE or any LVEF measurement <40%
Patients who are not candidates for Rate or Rhythm control drug therapy for AF
Dilated cardiomyopathy due to potentially reversible cause e.g. myocarditis
Contraindications to anticoagulant therapy or adverse event with prior Warfarin orDOAC therapy
Creatinine clearance <30ml/min or >95ml/min
Advanced hepatic disease, pulmonary disease clinically significant congenital heartdisease, clinically significant pericardial constriction, hypertrophiccardiomyopathy, infiltrative cardiomyopathy, decompensated valvular heart diseaselikely to require surgical or percutaneous intervention during the trial
Recent stroke (<3 months) or thromboembolic event, transient ischemic attack orcarotid angioplasty in the prior 3 months
Recent (<3 months) intracranial or other major bleeding event
Candidates for heart or any other organ transplantation or left ventricular assistdevices, recent (< 3 months) valve or other cardiac surgery
Patients requiring ACE inhibitor or ARB drug therapy for any reason
History of hypersensitivity to antiarrhythmic drugs
Patients with other clinically significant medical condition that precludes studyparticipation
Patients with life expectancy < 1 year
Premenopausal female patients, who are not on continuous birth control therapy orare likely to discontinue it at any time during the entire duration of studyenrollment.
Pregnant or nursing lactating mothers or women of childbearing potential who are noton effective contraceptive therapy
Patients who have been noncompliant with medical regimens or have social or otherissues precluding regular follow up, history of alcohol or drug abuse in past 12months.
Study Design
Study Description
Connect with a study center
Peter Osypka Herzzentrum
Munich, Bavaria 81379
GermanySite Not Available
Hopitaux Universitaires de Geneve
Geneva, Geneve 1205
SwitzerlandActive - Recruiting
Northern Arizona Health Care
Flagstaff, Arizona 86001
United StatesActive - Recruiting
Arizona Heart Rhythm Center
Phoenix, Arizona 85016
United StatesSite Not Available
St. Bernards Heart and Vascular Center
Jonesboro, Arkansas 72401
United StatesActive - Recruiting
South Denver Cardiology
Littleton, Colorado 80120
United StatesActive - Recruiting
Kansas City Heart Rhythm Institute
Overland, Missouri 66211
United StatesActive - Recruiting
Electrophysiology Research Foundation
Warren, New Jersey 07059
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
TCAI at St. David's Hospital
Austin, Texas 78705
United StatesActive - Recruiting

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