Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs
NCT ID: NCT06740539
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
304 participants
INTERVENTIONAL
2024-12-16
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ablation Group
Ablation Group: Received heart failure treatment combined with ablation
Catheter ablation of atrial fibrillation
Catheter ablation of atrial fibrillation
Drug Control Group
Received heart failure treatment combined with heart rate control.
No interventions assigned to this group
Interventions
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Catheter ablation of atrial fibrillation
Catheter ablation of atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
* The patient is willing and able to comply with the protocol and has provided written informed consent.
* Paroxysmal or persistent atrial fibrillation (AF).（Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than seven days but necessitating pharmacologic or electric cardioversion. Included within the category of persistent AF 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 other suitable device.）
* Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs.
* Diagnosed with Heart Failure with Preserved Ejection Fraction (HFpEF).（(1) a history of 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 following cardiac structural abnormalities identified by echocardiography: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction; and (4) elevated levels 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 at admis-sion.)
* New York Heart Association class II, III, or IV.
Exclusion Criteria
* Contraindication to chronic anticoagulation therapy or heparin.
* Documented left atrial diameter \>6 cm, optimally from the parasternal long-axis view.
* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 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 contraceptive measures during fertility age.
* Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.
18 Years
ALL
No
Sponsors
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The Third Affiliated Hospital of Anhui Medical University
UNKNOWN
Hefei Second People's Hospital
UNKNOWN
The Second People's Hospital of Anhui Province
OTHER
Hefei Binhu Hospital
OTHER
Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
Professor
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Mu Qin
Role: primary
Other Identifiers
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CAPHF-AF
Identifier Type: -
Identifier Source: org_study_id