Mitral RegurgitationTENDERNCT04898335
Tendyne European Experience Registry
An observational study of Mitral Regurgitation, run by LMU Klinikum at 30 sites in 10 countries.
Trial summary
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Tendyne Mitral Valve System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 30 sitesin 10 countries
- Study dates
- 15 Apr 2021to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.
Who may be able to join
- Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
- Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements
Who cannot join
- Patients not providing written informed consent
Trial locations and contacts
30 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Mirjam Wild, MD contact
30 sites in 10 countries
Germany12 sites, 12 recruiting
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Tanja Rudolph
- Recruiting
Deutsches Herzzentrum Berlin
Berlin
Axel Unbehaun
- Recruiting
Universitaetsklinikum Bonn
Bonn
Alexander Sedaghat
- Recruiting
Universitaetsklinikum Koeln
Cologne
Stephan Baldus
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt
Thomas Walther
- Recruiting
UKE Hamburg
Hamburg
Leonard Conradi
- Not yet recruiting
Herzentrum Leipzig
Leipzig
Philipp Lurz
- Recruiting
Universitätsmedizin Mainz
Mainz
Stephan von Bardeleben
- Recruiting
DHZ München
Münich
Hendrik Ruge
- Not yet recruiting
Universitaetsklinikum Regensburg
Regensburg
Bernhard Unsoeld
- Not yet recruiting
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart
Philipp Nikolai
- Recruiting
Universitaetsklinikum Tuebingen
Tübingen
Tobias Geisler
France4 sites, 4 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Thomas Modine
- Recruiting
CHU de Lille
Lille
Augustin Coisine
- Not yet recruiting
CHU Rennes
Rennes
Christophe Leclercq
- Recruiting
Clinique Pasteur
Toulouse
Nicolas Dumonteil
Spain4 sites, 4 recruiting
- Recruiting
Puerto de Hierro Madrid
Madrid
Vanessa Monivas
- Recruiting
University hospital Madrid
Madrid
Luis Nombela
- Recruiting
Hospital Clinico Valladolid
Valladolid
Ignacio Amat-Santos
- Recruiting
University Hospital of Vigo
Vigo
Rodrigo Estevez-Loureiro
Austria2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Linz
Linz
Andreas Zierer
- Recruiting
Universitaetsklinikum Wien
Vienna
Martin Andreas
Italy2 sites, 2 recruiting
- Recruiting
ICH - Istituto Clinico Humanitas
Milan
Andrea Fumero
- Recruiting
University Hospital of Pisa
Pisa
Anna Sonia Petronio
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Universitaetsspital Basel
Basel
Oliver Reuthebuch
- Recruiting
Inselspital Bern
Bern
Fabien Praz
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Stockholm
Stockholm
Andreas Rueck
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton London
London
Alison Duncan
About this study
Official title: TENDyne European expeRience Registry
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
Read the detailed description
Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.
TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.
- Conditions
- Mitral Regurgitation
- Being tested
- Tendyne Mitral Valve System
- Keywords
- mitral regurgitation, Tendyne, transcatheter mitral valve replacement
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendyne Mitral Valve SystemDevice
Tendyne Mitral Valve System for mitral valve disease in a commercial setting
| Study group | Role | What they receive |
|---|---|---|
| Tendyne | all patients treated with a Tendyne Mitral Valve System Receives: Device: Tendyne Mitral Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of procedural success
Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure
Measured: 30 days
Secondary outcomes (16)
Rate of peri-procedural myocardial infarction
Myocardial infarction during the index procedure
Measured: 1 day
Rate of conversion to open-heart surgery
Conversion to open-heart surgery during the index procedure
Measured: 1 day
Rate of cardiac tamponade
Cardiac Tamponade during the index procedure
Measured: 1 day
Rate of procedural mortality
Death during the index procedure
Measured: 1 day
Rate of technical success (cumulative endpoint according to MVARC)
Absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery) Device success (according to MVARC): absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg)
Measured: 1 day
Rate of device success (cumulative endpoint according to MVARC)
Absence of procedural mortality or stroke, proper placement and positioning, freedom from unplaned procedure related to the device or access, continued safety and performance of the device (no structural or functional failure, no technical complications, reduction of MR ≤ 2+ and mitral valve gradient < 5 mmHg)
Measured: 30 days, 1 year and 3 years
New York Heart Association (NYHA) functional class
class I - IV
Measured: 30 days, 1 year and 3 years
6-minute walk distance (6MWD)
in m
Measured: 30 days, 1 year and 3 years
BNP/NT-proBNP level
in pg/ml
Measured: 30 days, 1 year and 3 years
Mitral regurgitation severity grade
grade 0/1+/2+/3+/4+
Measured: 30 days, 1 year and 3 years
Left and right ventricular dimensions
left/right ventricular end-diastolic/-systolic diameter (in mm)
Measured: 30 days, 1 year and 3 years
Left ventricular function
LVEF in percent
Measured: 30 days, 1 year and 3 years
Right ventricular function
TAPSE in mm
Measured: 30 days, 1 year and 3 years
Pulmonary artery pressure
in mmHg
Measured: 30 days, 1 year and 3 years
Tricuspid regurgitation severity grade
grade 1-5
Measured: 30 days, 1 year and 3 years
Transprosthetic gradient
in mmHg
Measured: 30 days, 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Jörg Hausleiter, LMU Klinikum
- Investigators
- Joerg Hausleiter, MD, Principal investigator, LMU Klinikum Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898335
- Sponsor's protocol ID
- 21-0110
- Acronym
- TENDER
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hell MM, Wild MG, Baldus S, Rudolph T, Treede H, Petronio AS, Modine T, Andreas M, Coisne A, Duncan A, Franco LN, Praz F, Ruge H, Conradi L, Zierer A, Anselmi A, Dumonteil N, Nickenig G, Pinon M, Barth S, Adamo M, Dubois C, Torracca L, Maisano F, Lurz P, von Bardeleben RS, Hausleiter J; TENDER Investigators. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC Cardiovasc Interv. 2024 Mar 11;17(5):648-661. doi: 10.1016/j.jcin.2023.12.027. Epub 2024 Feb 21.
PubMed 38385922
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENDyne European expeRience Registry
- ClinicalTrials.gov ID
- NCT04898335
- Acronym / sponsor ID
- TENDER / 21-0110
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, Tendyne, transcatheter mitral valve replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
Detailed description
Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.
TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tendyne | – | Device: Tendyne Mitral Valve Systemall patients treated with a Tendyne Mitral Valve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.
Key inclusion criteria (2 listed)
- Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
- Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements
Key exclusion criteria (1 listed)
- Patients not providing written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendyne Mitral Valve SystemTendyne Mitral Valve System for mitral valve disease in a commercial setting | Device | Tendyne |
Primary outcome
Rate of procedural success
Time frame: 30 days
Device success (structural and functional); absence of death, stroke, life-threatening bleeding, major vascular or cardiac structural complications, acute kidney injury, myocardial infarction, heart failure and valve-related dysfunction requiring repeat procedure
16 secondary outcomes
Rate of peri-procedural myocardial infarction
Time frame: 1 day
Rate of conversion to open-heart surgery
Time frame: 1 day
Rate of cardiac tamponade
Time frame: 1 day
Rate of procedural mortality
Time frame: 1 day
Rate of technical success (cumulative endpoint according to MVARC)
Time frame: 1 day
Rate of device success (cumulative endpoint according to MVARC)
Time frame: 30 days, 1 year and 3 years
New York Heart Association (NYHA) functional class
Time frame: 30 days, 1 year and 3 years
6-minute walk distance (6MWD)
Time frame: 30 days, 1 year and 3 years
BNP/NT-proBNP level
Time frame: 30 days, 1 year and 3 years
Mitral regurgitation severity grade
Time frame: 30 days, 1 year and 3 years
Left and right ventricular dimensions
Time frame: 30 days, 1 year and 3 years
Left ventricular function
Time frame: 30 days, 1 year and 3 years
Right ventricular function
Time frame: 30 days, 1 year and 3 years
Pulmonary artery pressure
Time frame: 30 days, 1 year and 3 years
Tricuspid regurgitation severity grade
Time frame: 30 days, 1 year and 3 years
Transprosthetic gradient
Time frame: 30 days, 1 year and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 38385922Hell MM, Wild MG, Baldus S, Rudolph T, Treede H, Petronio AS, Modine T, Andreas M, Coisne A, Duncan A, Franco LN, Praz F, Ruge H, Conradi L, Zierer A, Anselmi A, Dumonteil N, Nickenig G, Pinon M, Barth S, Adamo M, Dubois C, Torracca L, Maisano F, Lurz P, von Bardeleben RS, Hausleiter J; TENDER Investigators. Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. JACC Cardiovasc Interv. 2024 Mar 11;17(5):648-661. doi: 10.1016/j.jcin.2023.12.027. Epub 2024 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirjam Wild, MD contact
Joerg Hausleiter, MD principal investigator
LMU Klinikum Munich
30 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by LMU Klinikum at 30 sites in 10 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, France, Spain, Austria, Italy and 5 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joerg Hausleiter, MD (0049894400 ext. 72360, joerg.hausleiter@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of procedural success (time frame: 30 days). 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 NCT04898335, which also lists 1 linked publication.
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 24 May 2021.