Phase
Condition
Congestive Heart Failure
Chest Pain
Hyponatremia
Treatment
Catheter ablation of atrial fibrillation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years.
The patient is willing and able to comply with the protocol and has provided writteninformed consent.
Paroxysmal or persistent atrial fibrillation (AF).(Persistent AF was defined as AFwhich is sustained beyond 7 days, or lasting less than seven days but necessitatingpharmacologic or electric cardioversion. Included within the category of persistentAF is 'long-standing persistent AF', defined as continuous AF of >1-year duration.AF episodes had to be documented in the last 3 months prior to enrollment by ECG,Holter ECG, Loop Recorder, memory of the implanted device (ICD/CRT-D), or any othersuitable device.)
Failure or intolerance of antiarrhythmic drug therapy or unwillingness to takeantiarrhythmic drugs.
Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).((1) a historyof hospitalization for HF with symptoms classified as New York Heart Association (NYHA) class II, III, or IV; (2) LVEF ≥ 50%; (3) at least one of the followingcardiac structural abnormalities identified by echocardiography: left ventricularhypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevatedlevels of N-terminal pro-brain natriuretic peptide (NT-proBNP), with a threshold of ≥400 pg/mL for pa-tients with SR at admission and ≥600 pg/mL for patients with AF atadmis-sion.)
New York Heart Association class II, III, or IV.
Exclusion
Exclusion Criteria:
Previous left heart ablation procedure for AF.
Contraindication to chronic anticoagulation therapy or heparin.
Documented left atrial diameter >6 cm, optimally from the parasternal long-axisview.
Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accidentwithin 2 months prior to enrollment.
Planned cardiovascular intervention.
Listed for heart transplant.
Cardiac assist device implanted.
Life expectancy ≤ 12 months.
Mental or physical inability to participate in the study.
Requirement for dialysis due to terminal renal failure.
Woman currently pregnant or breastfeeding or not using reliable contraceptivemeasures during fertility age.
Enrollment in another investigational drug or device study, or participation inanother telemonitoring concept.
Study Design
Connect with a study center
Shanghai Chest Hospital
Shanghai,
ChinaSite Not Available

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