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Clinical Trials/NL-OMON56877
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

Charité Universitätsmedizin Berlin0 sites150 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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