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NCT06740539Not yet recruiting

Atrial Fibrillation with Heart Failure with Preserved Ejection Fraction: Treatment Strategies-Catheter Ablation Vs. Anti-Atrial Arrhythmia Drugs

Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

A comparison of whether catheter ablation improves the prognosis (all-cause mortality and/or the composite endpoint of MACE) and reduces the recurrence rate of atrial fibrillation (AF) in patients with AF and heart failure with preserved ejection fraction (HFpEF), compared to anti-atrial arrhythmia drugs (AAD). This trial was randomly divided into two groups: the anti-AAD drug group and the catheter ablation group.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
304 (estimated)
First submitted
15 Dec 2024
Start date
16 Dec 2024
Primary completion date
1 Jan 2027
Lead sponsor
Shanghai Chest Hospital
NCT number
NCT06740539

What you commit to

  • Study type: Interventional
  • Planned participants: 304
  • From 16 Dec 2024 to the primary completion date, 1 Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous left heart ablation procedure for AF.
  • Contraindication to chronic anticoagulation therapy or heparin.
  • Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.
  • Enrollment in another investigational drug or device study, or participation in another telemonitoring concept.

Other illness

  • Listed for heart transplant.
  • Cardiac assist device implanted.
  • Requirement for dialysis due to terminal renal failure.

Age

  • Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age.

Other

  • Documented left atrial diameter \>6 cm, optimally from the parasternal long-axis view.
  • Planned cardiovascular intervention.
  • Life expectancy ≤ 12 months.
  • Mental or physical inability to participate in the study.

Who the study is looking for

  • Age ≥18 years.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.