Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
NCT ID: NCT01570517
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2012-05-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device implantation
Subjects are implanted with the study device.
IASD System
Implantation of the DC Devices Inc. IASD System
Interventions
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IASD System
Implantation of the DC Devices Inc. IASD System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Corvia Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Komtebedde, DVM
Role: STUDY_CHAIR
DC Devices
Locations
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David Kaye
Melbourne, , Australia
Homolka Hospital
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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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.
Other Identifiers
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2011-01
Identifier Type: -
Identifier Source: org_study_id
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