CAtheter-Based Ablation of atrial fibrillation compared to conventional treatment in patients with Heart Failure with Preserved Ejection Fraction - Investigator-initiated, prospective, parallel-group, randomized, open, blinded endpoint assessment (PROBE), interventional multicenter strategy trial - CABA-HFpEF-DZHK27

Charité Universitätsmedizin Berlin0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•1. Age >=18 years
•2. Signed written informed consent
•3. Clinical evidence of symptomatic heart failure (NYHA class II-III)
•4. Paroxysmal or persistent atrial fibrillation (less than 24 months after
•first diagnosis, documented at
•least on one 12-lead ECG)
•5. Left ventricular ejection fraction (LVEF) 40-49% OR LVEF >=50% with at least
•one of the following
•HFpEF echocardiography findings (any local measurement made during the
•screening epoch):
•a. Left atrial (LA) enlargement defined by at least 1 of the following: LA
•width (diameter) >=3.8
•cm or LA length >=5.0 cm or LA area >=20 cm2 or LA volume >=55 ml or LA volume
•index >=29
•b. Left ventricular hypertrophy (septal thickness or posterior wall thickness
•>=1.1cm or relative
•wall thickness >0.42)
•6. Patients with at least 1 of the following:
•a. HF hospitalization (defined as HF listed as the major reason for
•hospitalization) within 6
•months prior to the screening visit and NT-proBNP >200 pg/ml for patients in
•sinus rhythm
•(SR) or >600 pg/ml for patients in AF at the time of blood sampling
•b. NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on
•screening ECG

•1. Patient is unable or unwilling to provide informed consent
•2. Patient is not suitable for rhythm control of AF
•3. Previous left atrial CA or surgical therapy of AF
•4. Acutely decompensated HF, NYHA IV (patients can be enrolled after
•stabilization)
•5. Valvular heart disease needing interventional or surgical treatment within 3
•6. Heart surgery planned within 3 months
•7. Prior heart transplant or listed for heart transplant or cardiac assist
•device implantation
•8. Untreated hypothyroidism or hyperthyroidism (after successful treatment of
•thyroid dysfunction,
•patients may be enrolled)
•9. Patient has contra-indication to oral anticoagulation
•10. Any disease that limits life expectancy to less than 1 year
•11. Active systemic infection (after successful treatment of infection,
•patients may be enrolled)
•12. Women currently pregnant or breastfeeding or women of childbearing
•potential without highly
•effective contraception (PEARL-Index < 1%),
•13. Patient is included in another clinical trial
•14. Inability to comply with the study procedures

发起方