REDUCE LAP-HF III Corvia Protocol 1701

NCT ID: NCT03191656

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-12

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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IASD Implant

Implantation of the IASD device using trans-septal puncture and the IASD system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corvia Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herzzentrum der Kerckhoff-Klinik

Bad Nauheim, , Germany

Site Status RECRUITING

Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für Kardiologie

Bad Oeynhausen, , Germany

Site Status RECRUITING

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Site Status RECRUITING

Unfallkrankenhaus Berlin

Berlin, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

Herzzentrum der Universität zu Köln

Cologne, , Germany

Site Status RECRUITING

Klinikum Lippe GmbH

Detmold, , Germany

Site Status TERMINATED

Herzzentrum Dresden GmbH

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. Angiologie

Düsseldorf, , Germany

Site Status RECRUITING

Elisabeth-Krankenhaus Essen

Essen, , Germany

Site Status TERMINATED

Universitätsklinikum Gießen

Giessen, , Germany

Site Status RECRUITING

Universitätsklinikum Göttingen

Göttingen, , Germany

Site Status RECRUITING

Universitäts Klinikum Halle

Halle, , Germany

Site Status RECRUITING

Klinikum am Plattenwald Bad Friedrichshall

Heilbronn, , Germany

Site Status TERMINATED

Klinikum Karlsburg

Karlsburg, , Germany

Site Status RECRUITING

Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische

Kiel, , Germany

Site Status TERMINATED

Klinikum Sankt Georg

Leipzig, , Germany

Site Status TERMINATED

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

Universitätsklinikum Munster

Münster, , Germany

Site Status RECRUITING

Niels-Stensen-Kliniken - Marienhospital

Osnabrück, , Germany

Site Status TERMINATED

St Vincenz-Kranenhaus

Paderborn, , Germany

Site Status TERMINATED

Herz-Kreislauf-Zentrum Rotenburg

Rotenburg (Wümme), , Germany

Site Status TERMINATED

Helios Kliniken Schwerin

Schwerin, , Germany

Site Status RECRUITING

Universitätsklinik Ulm-Keßler

Ülm, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Paul Gerhardt Stift - Unfallstation

Wittenberg, , Germany

Site Status RECRUITING

Heinrich Braun Klinikum

Zwickaü, , Germany

Site Status RECRUITING

Bürgelspital Solothurn

Solothurn, , Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Jan Komtebedde, DVM

Role: CONTACT

978-654-6113

Felix DeLaRosa

Role: CONTACT

Facility Contacts

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Mortiz Hass, MD

Role: primary

Daniel Dumitrescu, MD

Role: primary

Leon Iden, MD

Role: primary

Sebasian Winkler, MD

Role: primary

Karim Ibrahim, MD

Role: primary

Roman Pfister, MD

Role: primary

Axel Linke, MD

Role: primary

Ralf Westenfeld, MD

Role: primary

Holger Nef, MD

Role: primary

Gerd Hasenfuss, MD

Role: primary

J Tongers, MD

Role: primary

Basil Alkhlout, MD

Role: primary

T. Schmidt, MD

Role: primary

Rudin Pistulli, MD

Role: primary

Pauline Herke

Role: primary

Mirjam Kessler, MD

Role: primary

Franz Kleber, Prof

Role: primary

Holger Sigusch, MD

Role: primary

Rolf Vogel, Prof

Role: primary

Other Identifiers

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1701

Identifier Type: -

Identifier Source: org_study_id

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