Back to resultsFeasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IASD System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- David Kaye
- Homolka Hospital
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device implantation
Arm Description
Subjects are implanted with the study device.
Outcomes
Primary Outcome Measures
Serious Adverse Device Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570517
Brief Title
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
Official Title
Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corvia Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device implantation
Arm Type
Experimental
Arm Description
Subjects are implanted with the study device.
Intervention Type
Device
Intervention Name(s)
IASD System
Intervention Description
Implantation of the DC Devices Inc. IASD System
Primary Outcome Measure Information:
Title
Serious Adverse Device Events
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Komtebedde, DVM
Organizational Affiliation
DC Devices
Official's Role
Study Chair
Facility Information:
Facility Name
David Kaye
City
Melbourne
Country
Australia
Facility Name
Homolka Hospital
City
Prague
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24961390
Citation
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.
Results Reference
result
PubMed Identifier
25841123
Citation
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.
Results Reference
result
Learn more about this trial
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
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