Clinical trial NCT01570517: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Corvia Medical
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Serious Adverse Device Events
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: David Kaye
city: Prague
country: Czechia
facility: Homolka Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: DC Devices
name: Jan Komtebedde, DVM
role: STUDY_CHAIR
References:
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.
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.