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
1 other identifier
interventional
11
3 countries
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started May 2012
Typical duration for not_applicable heart-failure
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 15, 2020
July 1, 2020
2.4 years
March 21, 2012
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Serious Adverse Device Events
One month
Study Arms (1)
Device implantation
EXPERIMENTALSubjects are implanted with the study device.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corvia Medicallead
Study Sites (3)
David Kaye
Melbourne, Australia
Homolka Hospital
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Related Publications (2)
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.
PMID: 24961390RESULTMalek 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.
PMID: 25841123RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Komtebedde, DVM
DC Devices
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
April 4, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
July 15, 2020
Record last verified: 2020-07