RecruitingNot ApplicableNCT06125925

Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: an International, Prospective, Multi-center, Randomized Controlled Study (STABLE-SR IV Trial)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

436 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial (STABLE-SR IV) is testing whether a procedure called catheter ablation — which uses radiofrequency energy to correct abnormal heart rhythms — improves outcomes in patients who have both atrial fibrillation (an irregular heartbeat) and a type of heart failure called HFpEF (heart failure with preserved ejection fraction). **You may be eligible if:** - You have symptomatic atrial fibrillation (paroxysmal or persistent) - You have been diagnosed with HFpEF, including symptoms like shortness of breath and evidence of abnormal heart filling on echocardiogram - Your heart pumps normally (ejection fraction at least 50%) - You have elevated heart-strain markers (NT-proBNP above certain thresholds) **You may NOT be eligible if:** - You have a life expectancy under 2 years from a non-cardiac cause - Your atrial fibrillation is caused by a reversible condition like thyroid disease - You have had prior ablation for atrial fibrillation - Your left atrium is significantly enlarged (55 mm or more) - You have had a heart attack, stroke, or cardiac surgery within the past 12 weeks - Your body mass index (BMI) is above 50 - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERadiofrequency catheter ablation (RFCA)

Radiofrequency ablation is adopted in the study, instead of cryo ablation, surgical ablation or pulsed field ablation. 3-dimensional model is constructed after transseptal puncture. Circumferential pulmonary vein isolation (CPVI) is performed with irrigated contact force catheter. Previously published STABLE-SR approach is recommended as the ablation strategy beyond CPVI.

DRUGMedical Therapy

AADs should be prescribed according to the current guidelines, such as amiodarone, dronedarone, or propafenone. In brief, rhythm control is preferred, including electric cardioversion. However, rate control should be considered if rhythm control is contraindicated, intolerated or unpreferred by patients.


Locations(1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, China

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NCT06125925


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