Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System

Heart Failure Clinical Trial

Official title:

Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570517
• Other study ID #: 2011-01
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2020
• Source: Corvia Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• IASD System
Implantation of the DC Devices Inc. IASD System

Locations

Country	Name	City	State
Australia	David Kaye	Melbourne
Czechia	Homolka Hospital	Prague
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Corvia Medical

Countries where clinical trial is conducted

Australia,  Czechia,  Denmark, 

References & Publications (2)

Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Søndergaard 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 Cardi — View Citation

Søndergaard 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 p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Device Events		One month