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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03191656
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : September 30, 2021
Information provided by (Responsible Party):
Corvia Medical

Brief Summary:
This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a "real world" practice setting.

Condition or disease Intervention/treatment
Heart Failure Device: IASD Implant

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Intervention Details:
  • Device: IASD Implant
    Implantation of the IASD device using trans-septal puncture and the IASD system

Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 30 days ]
    Device and or procedure related serious adverse cardiac events

  2. New York Heart Classification [ Time Frame: 12 months ]
    Improvement in NYHA Classification

  3. Quality of Life Improvement (KCCQ score) [ Time Frame: 12 months ]
    Improvement in KCCQ score

  4. Quality of Life Improvement (EQ5D) [ Time Frame: 12 months ]
    Improvement in EQ5D score

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT), in accordance with CE-mark approved labeling.
This is a post market registry so no criteria requirements (only recommendations).

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 identifier (NCT number): NCT03191656

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Contact: Jan Komtebedde, DVM 978-654-6113
Contact: Katie Romcevich

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Sponsors and Collaborators
Corvia Medical
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Responsible Party: Corvia Medical Identifier: NCT03191656    
Other Study ID Numbers: 1701
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases