JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

NCT01598844 | Completed

• 1 other identifier: JV03PMS
• Study Type: observational
• Target: 210
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

Conditions

Aortic Stenosis; Aortic Insufficiency; Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve prosthesis irrespective of the underlying cause of death.

  30 day

Secondary Outcomes (6)

• Safety Endpoints

  peri- and post-operatively and at 3, 6, 12, 24 and 36 months

• Device Success

  Index Procedure and Immediate Post-operative

• Device Effectiveness

  Prior to discharge, at 3, 6, 12, 24 and 36 months

• SF-12 Survey of Quality of Life

  at 12 months

• Combined Safety Endpoint

  at 30 days

Study Arms (2)

High risk patients with aortic stenosis

Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.

Device: Transcatheter aortic valve replacement

High risk patients with AI

Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.

Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacement DEVICE

Transcatheter aortic valve replacement via a transapical access

Also known as: The JenaValve TAVI System

High risk patients with AI; High risk patients with aortic stenosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic stenosis or with severe aortic insufficiency and an increased risk for an open aortic valve replacement surgery

You may qualify if:

• Patients suitable for TAVI with the JenaValve according to instructions for use

You may not qualify if:

• Patients unsuitable for TAVI with the JenaValve according to instructions for use

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead
• King's College London: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (15)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Herzzentrum der Universität

Cologne, Germany

Location

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Location

University Hospital

Erlangen, Germany

Location

University Heart Centre

Freiburg im Breisgau, Germany

Location

Asklepios Klinik

Hamburg, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, Germany

Location

Herzzentrum Leipzig - Universitätsklinik

Leipzig, Germany

Location

Deutsches Herzzentrum München

Munich, Germany

Location

Herzzentrum des Städtischen Klinikums München

Munich, Germany

Location

Herz- und Kreislaufzentrum Rotenburg (Fulda)

Rotenburg an der Fulda, Germany

Location

Robert Bosch Krankenhaus Stuttgart

Stuttgart, Germany

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Universitätsspital Basel

Basel, Switzerland

Location

King's College Hospital

London, United Kingdom

Location

Related Publications (4)

• Mieres J, Menendez M, Fernandez-Pereira C, Rubio M, Rodriguez AE. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk. Case Rep Cardiol. 2015;2015:458151. doi: 10.1155/2015/458151. Epub 2015 Aug 4.

  PMID: 26346128 BACKGROUND

• Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schafer U, Diemert P, Treede H. Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.

  PMID: 25129672 BACKGROUND

• Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Ruter F, de Kroon TL, Lange R, Ensminger S, Wendler O. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Eur J Cardiothorac Surg. 2016 Nov;50(5):874-881. doi: 10.1093/ejcts/ezw170. Epub 2016 May 30.

  PMID: 27242354 RESULT

• Silaschi M, Conradi L, Wendler O, Schlingloff F, Kappert U, Rastan AJ, Baumbach H, Holzhey D, Eichinger W, Bader R, Treede H. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 2018 Jun;91(7):1345-1351. doi: 10.1002/ccd.27370. Epub 2017 Nov 24.

  PMID: 29171730 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Olaf Wendler, Prof

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Hendrik Treede, Prof

  University Heart Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: May 30, 2012
• Primary Completion: August 27, 2015
• Study Completion: July 31, 2018
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

NL (1); DE (12); GB (1); CH (1)