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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01570517




Registration number
NCT01570517
Ethics application status
Date submitted
21/03/2012
Date registered
4/04/2012
Date last updated
15/07/2020

Titles & IDs
Public title
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
Scientific title
Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
Secondary ID [1] 0 0
2011-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IASD System

Experimental: Device implantation - Subjects are implanted with the study device.


Treatment: Devices: IASD System
Implantation of the DC Devices Inc. IASD System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serious Adverse Device Events
Timepoint [1] 0 0
One month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
David Kaye - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corvia Medical
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01570517
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Jan Komtebedde, DVM
Address 0 0
DC Devices
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01570517