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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570517
First Posted: April 4, 2012
Last Update Posted: August 5, 2016
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.
Information provided by (Responsible Party):
Corvia Medical
  Purpose
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 Intervention Phase
Heart Failure Device: IASD System Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Corvia Medical:

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

Enrollment: 11
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device implantation
Subjects are implanted with the study device.
Device: IASD System
Implantation of the DC Devices Inc. IASD System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
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
Australia
David Kaye
Melbourne, Australia
Czech Republic
Homolka Hospital
Prague, Czech Republic
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Corvia Medical
Investigators
Study Chair: Jan Komtebedde, DVM DC Devices
  More Information

Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT01570517     History of Changes
Other Study ID Numbers: 2011-01
First Submitted: March 21, 2012
First Posted: April 4, 2012
Last Update Posted: August 5, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases