NCT02732691

Brief Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
4 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

October 21, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 22, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

November 22, 2022

Status Verified

October 1, 2022

Enrollment Period

2.6 years

First QC Date

March 18, 2016

Results QC Date

September 7, 2022

Last Update Submit

October 28, 2022

Conditions

Aortic Valve StenosisHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Keywords

Valvular Heart DiseaseCritical/Severe Aortic StenosisHigh risk symptomatic patients

Outcome Measures

Primary Outcomes (1)

  • All-Cause Mortality

    All-cause mortality rate at 30 Day

    30 Day

Secondary Outcomes (10)

  • Myocardial Infarction

    30 Day

  • All Stroke/TIA

    30 Day

  • Major Bleeding

    30 Day

  • Major Vascular Complication

    30 Day

  • Conduction Disturbance and Arrhythmias

    30 Day

  • +5 more secondary outcomes

Study Arms (1)

Transcatheter Aortic Valve Replacement (TAVR)

EXPERIMENTAL

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.

Device: JenaValve Pericardial TAVR System

Interventions

JenaValve Pericardial TAVR SystemDEVICE

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with severe degenerative native aortic stenosis (AS).
  • Patient at high risk for open surgical valve replacement
  • Patient symptomatic according to NYHA functional class II or higher

You may not qualify if:

  • Congenital uni- or bicuspid aortic valve morphology
  • Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
  • Endocarditis or other active infection
  • Need for urgent or emergent TAVR procedure for any reason
  • Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Herzzentrum der Universität zu Köln

Cologne, 50937, Germany

Location

Universitäts-Herzzentrum Freiburg/Bad Krozingen

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Halle

Halle, 6120, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Leiden University Medical Center

Leiden, 2333, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3435, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3062, Netherlands

Location

Auckland City Hospital

Auckland, 1142, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Related Publications (4)

  • Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.

    PMID: 28314623BACKGROUND

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.

    PMID: 28298458BACKGROUND

  • Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.

    PMID: 12831818BACKGROUND

  • Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.

    PMID: 34556282BACKGROUND

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Condition Hierarchy (Ancestors)

Aortic Valve Disease

Results Point of Contact

Title
Vinny Podichetty, Vice President: Clinical & Med Affairs
Organization
JenaValve Technologies Inc.
podichetty@jenavalve.com
949-767-2110

Study Officials

  • Martin B Leon, MD

    New York-Presbyterian Hospital/Columbia University Medical Center, USA

    STUDY CHAIR

  • Torsten P Vahl, MD

    New York-Presbyterian Hospital/Columbia University Medical Center, USA

    PRINCIPAL INVESTIGATOR

  • Vinod H Thourani, MD

    Piedmont Heart Institute, USA

    PRINCIPAL INVESTIGATOR

  • Hendrik Treede, MD

    University Hospital Bonn, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 11, 2016

Study Start

October 21, 2016

Primary Completion

May 28, 2019

Study Completion

April 1, 2024

Last Updated

November 22, 2022

Results First Posted

November 22, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)NZ(2)NL(3)DE(6)