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Trial record 4 of 4 for:    REDUCE LAP HF

REDUCE LAP-HF III Corvia Protocol 1701 (REDUCELAPHFIII)

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ClinicalTrials.gov Identifier: NCT03191656
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Corvia Medical

Brief Summary:
This is a post market trial to be conducted at several 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 : 100 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, 2021
Estimated Study Completion Date : July 31, 2021

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

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

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



Information from the National Library of Medicine

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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.
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT03191656


Contacts
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Contact: Jan Komtebedde, DVM 978-654-6113 jkomtebedde@corviamedical.com
Contact: Jennifer Seale, MPH 978-654-6124 jseale@corviamedical.com

Locations
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Germany
Klinikum Lippe GmbH Recruiting
Detmold, Germany
Contact: Stephan Gielen, MD         
Elisabeth-Krankenhaus Essen Recruiting
Essen, Germany
Contact: Oliver Bruder, MD         
Universitäts Klinikum Halle Recruiting
Halle, Germany
Contact: Michel Noutsias, MD         
St Vincenz-Kranenhaus Recruiting
Paderborn, Germany
Contact: Andreas Goette, MD         
Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation Recruiting
Wittenberg, Germany
Contact: Franz Kleber, Prof         
Switzerland
Bürgelspital Solothurn Recruiting
Solothurn, Switzerland
Contact: Rolf Vogel, Prof         
Sponsors and Collaborators
Corvia Medical

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Responsible Party: Corvia Medical
ClinicalTrials.gov Identifier: NCT03191656     History of Changes
Other Study ID Numbers: 1701
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases