- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570517
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of HFpEF
- Ejection Fraction of at least 45%
- Imaging and hemodynamic evidence of HFpEF
- History of exercise intolerance
- Symptomatic despite optimal medical management
- Signed study specific informed consent
Exclusion Criteria:
- History of thromboembolic events
- Significant structural heart disease or coronary artery disease
- Contraindicated to study required medication
- Right ventricular dysfunction
- History of greater than mild restrictive or obstructive lung disease
- Life expectancy less than one year for non-cardiovascular reasons
- Known or suspected allergy to implant material
- Fertile women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device implantation
Subjects are implanted with the study device.
|
Implantation of the DC Devices Inc. IASD System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serious Adverse Device Events
Time Frame: One month
|
One month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jan Komtebedde, DVM, DC Devices
Publications and helpful links
General Publications
- Sondergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M, Franzen O, Neuzil P, Ihlemann N, Gustafsson F. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. Eur J Heart Fail. 2014 Jul;16(7):796-801. doi: 10.1002/ejhf.111. Epub 2014 Jun 24.
- Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Sondergaard L, Ihlemann N, Mariani JA, Reddy V. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-8. doi: 10.1016/j.ijcard.2015.03.198. Epub 2015 Mar 18. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on IASD System
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ResMedCompleted
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Federal University of São PauloCompletedAdverse Reaction to Systemic AgentsBrazil