Heart Failure Clinical Trial
Official title:
Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
The study was a multi-center, non-randomized feasibility evaluation of the IASD System at
three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics
committee and competent authority approvals were obtained. The study was conducted in
accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum
of 5 patients, and allowed up to twenty patients to be enrolled.
The primary objective of the trial was to evaluate the safety and potential benefits of the
IASD Device System in the treatment of patients with symptomatic heart failure with preserved
ejection fraction, despite optimal medical management.
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