NL-OMON56877
Not yet recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial fibrillation and HFpEF
- Sponsor
- Charité Universitätsmedizin Berlin
- Enrollment
- 150
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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):
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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