REDUCE LAP-HF III Corvia Protocol 1701 (REDUCELAPHFIII)

February 6, 2024 updated by: Corvia Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Nauheim, Germany
        • Recruiting
        • Herzzentrum der Kerckhoff-Klinik
        • Contact:
          • Mortiz Hass, MD
      • Bad Oeynhausen, Germany
        • Recruiting
        • Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie
        • Contact:
          • Daniel Dumitrescu, MD
      • Bad Segeberg, Germany
        • Recruiting
        • Segeberger Kliniken Gmbh
        • Contact:
          • Leon Iden, MD
      • Berlin, Germany
        • Recruiting
        • Unfallkrankenhaus Berlin
        • Contact:
          • Sebasian Winkler, MD
      • Chemnitz, Germany
        • Recruiting
        • Klinikum Chemnitz gGmbH
        • Contact:
          • Karim Ibrahim, MD
      • Detmold, Germany
        • Terminated
        • Klinikum Lippe GmbH
      • Dresden, Germany
        • Recruiting
        • Herzzentrum Dresden GmbH
        • Contact:
          • Axel Linke, MD
      • Düsseldorf, Germany
        • Recruiting
        • Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie
        • Contact:
          • Ralf Westenfeld, MD
      • Essen, Germany
        • Terminated
        • Elisabeth-Krankenhaus Essen
      • Giessen, Germany
        • Recruiting
        • Universitätsklinikum Gießen
        • Contact:
          • Holger Nef, MD
      • Göttingen, Germany
        • Recruiting
        • Universitätsklinikum Göttingen
        • Contact:
          • Gerd Hasenfuss, MD
      • Halle, Germany
        • Recruiting
        • Universitäts Klinikum Halle
        • Contact:
          • J Tongers, MD
      • Heilbronn, Germany
        • Terminated
        • Klinikum am Plattenwald Bad Friedrichshall
      • Karlsburg, Germany
        • Recruiting
        • Klinikum Karlsburg
        • Contact:
          • Basil Alkhlout, MD
      • Kiel, Germany
        • Terminated
        • Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische
      • Köln, Germany
        • Recruiting
        • Herzzentrum der Universität zu Köln
        • Contact:
          • Roman Pfister, MD
      • Leipzig, Germany
        • Terminated
        • Klinikum Sankt Georg
      • Lübeck, Germany
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein
        • Contact:
          • T. Schmidt, MD
      • Münster, Germany
        • Recruiting
        • Universitätsklinikum Münster
        • Contact:
          • Rudin Pistulli, MD
      • Osnabrück, Germany
        • Terminated
        • Niels-Stensen-Kliniken - Marienhospital
      • Paderborn, Germany
        • Terminated
        • St Vincenz-Kranenhaus
      • Rotenburg, Germany
        • Terminated
        • Herz-Kreislauf-Zentrum Rotenburg
      • Schwerin, Germany, 19049
        • Recruiting
        • HELIOS Kliniken Schwerin
        • Contact:
          • Pauline Herke
        • Principal Investigator:
          • Philipp Hammer, MD
      • Wittenberg, Germany
        • Recruiting
        • Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation
        • Contact:
          • Franz Kleber, Prof
      • Zwickaü, Germany
        • Recruiting
        • Heinrich Braun Klinikum
        • Contact:
          • Holger Sigusch, MD
      • Ülm, Germany
        • Recruiting
        • Universitätsklinik Ulm-Keßler
        • Contact:
          • Mirjam Kessler, MD
  • Switzerland
      • Solothurn, Switzerland
        • Recruiting
        • Bürgelspital Solothurn
        • Contact:
          • Rolf Vogel, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

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.

Description

This is a post market registry so no criteria requirements (only recommendations).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: 30 days
Device and or procedure related serious adverse cardiac events
30 days
New York Heart Classification
Time Frame: 12 months
Improvement in NYHA Classification
12 months
Quality of Life Improvement (KCCQ score)
Time Frame: 12 months
Improvement in KCCQ score
12 months
Quality of Life Improvement (EQ5D)
Time Frame: 12 months
Improvement in EQ5D score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corvia Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2017

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 16, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1701

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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