JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

Aortic Stenosis Clinical Trial

— JUPITER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598844
• Other study ID #: JV03PMS
• Status: Completed
• Start date: May 30, 2012
• Est. completion date: July 31, 2018

Study information

• Verified date: November 2020
• Source: JenaValve Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: July 31, 2018
• Est. primary completion date: August 27, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Regurgitation
• Aortic Stenosis
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via a transapical access

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
JenaValve Technology, Inc.	King's College London, Universitätsklinikum Hamburg-Eppendorf

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (4)

Mieres J, Menéndez M, Fernández-Pereira C, Rubio M, Rodríguez 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. — View Citation

Seiffert M, Bader R, Kappert U, Rastan A, Krapf S, Bleiziffer S, Hofmann S, Arnold M, Kallenbach K, Conradi L, Schlingloff F, Wilbring M, Schäfer 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. — View Citation

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 va — View Citation

Silaschi M, Treede H, Rastan AJ, Baumbach H, Beyersdorf F, Kappert U, Eichinger W, Rüter 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	SF-12 Survey of Quality of Life	The SF-12 health survey to measure mental and physical health of the patient.	at 12 months
Secondary	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
Secondary	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