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Trial record 1 of 8 for:    IASD
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Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01570517
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: IASD System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
Study Start Date : May 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Device implantation
Subjects are implanted with the study device.
Device: IASD System
Implantation of the DC Devices Inc. IASD System




Primary Outcome Measures :
  1. Serious Adverse Device Events [ Time Frame: One month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570517


Locations
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Australia
David Kaye
Melbourne, Australia
Czechia
Homolka Hospital
Prague, Czechia
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Corvia Medical
Investigators
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Study Chair: Jan Komtebedde, DVM DC Devices
Publications of Results:
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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT01570517    
Other Study ID Numbers: 2011-01
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases