Text Size

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

This study is not yet open for participant recruitment.
Verified April 2012 by DC Devices, Inc.
Sponsor:
Information provided by (Responsible Party):
DC Devices, Inc.
ClinicalTrials.gov Identifier:
NCT01570517
First received: March 21, 2012
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by DC Devices, Inc.:

Primary Outcome Measures:
  • Serious Adverse Device Events [ Time Frame: One month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: IASD System
    Implantation of the DC Devices Inc. IASD System
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570517

Contacts
Contact: Anne Kulis 978-654-6110 akulis@dcdevicesinc.com

Sponsors and Collaborators
DC Devices, Inc.
  More Information

No publications provided

Responsible Party: DC Devices, Inc.
ClinicalTrials.gov Identifier: NCT01570517     History of Changes
Other Study ID Numbers: 2011-01
Study First Received: March 21, 2012
Last Updated: April 2, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013