AzTrials
AzTrials

Aortic Valve StenosisNCT02732691

JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

A study testing JenaValve Pericardial TAVR System in people with Aortic Valve Stenosis and Heart Valve Diseases, run by JenaValve Technology, Inc. at 13 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JenaValve Pericardial TAVR System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
13 sitesin 4 countries
Study dates
21 Oct 2016to Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Germany6 sites

  • Deutsches Herzzentrum Berlin

    Berlin, 13353

  • Herzzentrum der Universität zu Köln

    Cologne, 50937

  • Universitäts-Herzzentrum Freiburg/Bad Krozingen

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Halle

    Halle, 6120

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

Other trials in Germany

Netherlands3 sites

  • Leiden University Medical Center

    Leiden, 2333

  • St. Antonius Hospital

    Nieuwegein, 3435

  • Erasmus University Medical Center

    Rotterdam, 3062

Other trials in Netherlands

United States2 sites

  • Columbia University Medical Center

    New York, New York, 10032

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1142

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

About this study

Official title: JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

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.

Read the detailed description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Being tested
JenaValve Pericardial TAVR System
Keywords
Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients
Medical subject headings
Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Ventricular Outflow Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JenaValve Pericardial TAVR SystemDevice

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

Study groups in NCT02732691
Study groupRoleWhat they receive
Transcatheter Aortic Valve Replacement (TAVR)ExperimentalTranscatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Receives: Device: JenaValve Pericardial TAVR System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Mortality

    All-cause mortality rate at 30 Day

    Measured: 30 Day

Secondary outcomes (10)

  1. Myocardial Infarction

    Peri-procedural and spontaneous myocardial infarction

    Measured: 30 Day

  2. All Stroke/TIA

    Neurological Complications

    Measured: 30 Day

  3. Major Bleeding

    Life threatening or major bleeding

    Measured: 30 Day

  4. Major Vascular Complication

    Major vascular and bleeding complications

    Measured: 30 Day

  5. Conduction Disturbance and Arrhythmias

    Conduction system injury (defect), including AV block, which may require a permanent pacemaker

    Measured: 30 Day

  6. Acute Kidney Injury (AKI)

    Number of patients who were diagnosed with AKI Stage 2 or 3:

    AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output <0.5 mL/kg/h for >12 but <24 h

    AKI Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output <0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h

    Measured: 30 Day

  7. Coronary Obstruction Requiring Intervention

    Coronary obstruction post-implant requiring intervention

    Measured: 30 Day

  8. Endocarditis

    Bacterial endocarditis

    Measured: 30 Day

  9. Conversion to Surgical Aortic Valve Replacement (SAVR)

    Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications

    Measured: 30 Day

  10. THV Malpositioning

    Number of patients who experienced:

    Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences

    Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus

    Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root

    Measured: 30 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2016 (estimated)
  2. Study start21 Oct 2016
  3. Primary completion28 May 2019
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02732691
Sponsor's protocol ID
CP-0003
Other IDs
P02C220_JV06EFS_CIP, CA-0001 EU, CA-0001 Germany, CA-0010
Status last verified
Oct 2022
First submitted
18 Mar 2016
Last updated
22 Nov 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28314623

  • 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.

    PubMed 28298458

  • 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.

    PubMed 12831818

  • 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.

    PubMed 34556282

Questions about this trial

What is this clinical trial studying?

A study testing JenaValve Pericardial TAVR System in people with Aortic Valve Stenosis and Heart Valve Diseases, run by JenaValve Technology, Inc. at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Netherlands, United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality (time frame: 30 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732691, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in