Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
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|ClinicalTrials.gov Identifier: NCT01570517|
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: IASD System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Device implantation
Subjects are implanted with the study device.
Device: IASD System
Implantation of the DC Devices Inc. IASD System
- Serious Adverse Device Events [ Time Frame: One month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570517
|Study Chair:||Jan Komtebedde, DVM||DC Devices|