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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DC Devices, Inc.
ClinicalTrials.gov Identifier:
NCT01570517
First received: March 21, 2012
Last updated: February 13, 2014
Last verified: February 2014
  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:


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: December 2014
Estimated 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570517

Locations
Australia
David Kaye
Melbourne, Australia
Czech Republic
Homolka Hospital
Prague, Czech Republic
Denmark
Rigshospitalet
Copenhagen, Denmark
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: February 13, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014