JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation (JUPITER)

The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency

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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Aortic Regurgitation; Aortic Insufficiency
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

Detailed Description

The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.

The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW
  • Dresden, Germany
    • Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
  • Erlangen, Germany
    • University Hospital
  • Freiburg, Germany
    • University Heart Centre
  • Hamburg, Germany
    • Asklepios Klinik
  • Hamburg, Germany
    • Universitäres Herzzentrum Hamburg
  • Köln, Germany
    • Herzzentrum der Universität
  • Leipzig, Germany
    • Herzzentrum Leipzig - Universitätsklinik
  • Munich, Germany
    • Deutsches Herzzentrum München
  • Munich, Germany
    • Herzzentrum des Städtischen Klinikums München
  • Rotenburg An Der Fulda, Germany
    • Herz- und Kreislaufzentrum Rotenburg (Fulda)
  • Stuttgart, Germany
    • Robert Bosch Krankenhaus Stuttgart
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius ziekenhuis
• Switzerland
  • Basel, Switzerland
    • Universitatsspital Basel
• United Kingdom
  • London, United Kingdom
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High risk patients with aortic stenosis; Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.	Device: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement via a transapical access; Other Names: The JenaValve TAVI System
High risk patients with AI; Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.	Device: Transcatheter aortic valve replacement; Transcatheter aortic valve replacement via a transapical access; Other Names: The JenaValve TAVI System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	All-cause mortality; Cardiovascular mortality; Major stroke; Life-threatening or disabling bleeding; Major bleeding; Acute kidney injury; Myocardial infarction; Major vascular complication; Mechanical coronary obstruction; Prosthetic valve thrombus; Prosthetic valve endocarditis; Conduction disturbance and cardiac arrhythmia; Necessity of permanent pacemaker implantation	peri- and post-operatively and at 3, 6, 12, 24 and 36 months
Device Success	The following parameters will be collected to assess device success: Successful vascular access, delivery and deployment of the device successful retrieval of the device; Correct position of the device in the proper anatomical location; Intended performance of the prosthetic heart valve:; Only one valve implanted in proper anatomical position	Index Procedure and Immediate Post-operative
Device Effectiveness	The following parameters will assess effectiveness: Transvalvular aortic peak pressure gradient; Transvalvular aortic mean pressure gradient; Effective aortic valve area; Paravalvular regurgitation coded according to VARC; Transvalvular regurgitation coded according to VARC; No clinically significant valve migration/dislocation; Absence of mechanical coronary obstruction; Functional improvement assessment by NYHA functional classification	Prior to discharge, at 3, 6, 12, 24 and 36 months
SF-12 Survey of Quality of Life	The SF-12 health survey to measure mental and physical health of the patient.	at 12 months
Combined Safety Endpoint	A combined safety endpoint will be assessed at 30 days consisting of the following variables: All-cause mortality; Major stroke; Acute kidney injury (Stage 3); Life-threatening or disabling bleeding; Major vascular complication; Peri-procedural myocardial infarction; Repeat surgical or interventional procedure for valve-related dysfunction	at 30 days
Combined Efficacy Endpoint	A combined efficacy endpoint will be assessed consisting of the following variables: All-cause mortality (after > 30 days); Failure of current therapy for AS, requiring hospitalization for symptoms of valve-related or cardiac decompensation; Prosthetic heart valve dysfunction	at 12 months

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Collaborators: King's College London; Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Olaf Wendler, Prof, King's College Hospital, London; Principal Investigator: Hendrik Treede, Prof, University Heart Center Hamburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2012
• Primary Completion (Actual): August 27, 2015
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: May 11, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic
• Other Study ID Numbers: JV03PMS