Mitral Valve RegurgitationRESOLVE-MRNCT04818502
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
An observational study of Mitral Valve Regurgitation, run by Abbott Medical Devices at 36 sites in 13 countries.
Trial summary
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Tendyne™ Mitral Valve System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 36 sitesin 13 countries
- Study dates
- 4 May 2021to 31 May 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.
Who may be able to join
- Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
- Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
- Patient provides written informed consent prior to any study-specific procedure.
Who cannot join
- Patient is in another clinical study that may impact the follow-up or results of this study.
- Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
- Patient is under the age of 18 or age of legal consent.
- Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
Trial locations and contacts
36 sites in 13 countries.
36 sites in 13 countries
Germany12 sites
Heart and Diabetes Center NRW
Bad Oeynhausen
German Heart Center Berlin
Berlin
University Hospital Bonn
Bonn
Universitätsclinic Cologne
Cologne
University Hospital Frankfurt
Frankfurt
University Heart Center Hamburg
Hamburg
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
Leipzig Heart Center
Leipzig
University Medical Center Mainz
Mainz
Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern
München
German Heart Center Munich
Munich
Robert-Bosch Krankenhaus
Stuttgart
France5 sites
Bordeaux University Hospital
Bordeaux
CHRU de Lille
Lille
Lyon University Hospital
Lyon
Rennes University Hospital
Rennes
Clinique Pasteur
Toulouse
Czechia3 sites
University Hospital Olomouc
Olomouc
IKEM Prague
Prague
Hospital AGEL Trinec-Podlesi
Třinec
Italy3 sites
Lancisi Cardiovascular Center - Politechnic University of Marcher
Ancona
AOU Civili Brescia
Brescia
Azienda Ospedaliero Universitaria Pisana
Pisa
Saudi Arabia3 sites
King Fahad Armed Forces
Jeddah
King Fahad Medical City
Riyadh
King Faisal Specialist Hospital & Research Center
Riyadh
Switzerland2 sites
University Hospital Basel, Clinic for Cardiac Surgery
Basel
Insel Bern
Bern
About this study
Official title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
Read the detailed description
The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.
The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Tendyne™ Mitral Valve System
- Keywords
- Tendyne, Tendyne Mitral Valve System, Transcatheter, Mitral Regurgitation, Heart Valve disease, Mitral Valve Regurgitation, Mitral Insufficiency, Transcatheter intervention, Transcatheter Mitral Valve Implantation, Transcatheter Mitral Valve Replacement, Transapical Transcatheter Mitral Valve Implantation
- Medical subject headings
- Mitral Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendyne™ Mitral Valve SystemDevice
Also called Transcatheter Mitral Valve Implantation (TMVI)
Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint for MR Elimination at 1 Year
The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR < Grade I (mild, measured by Echocardiographic Core Lab)
Measured: At 1 year
Secondary outcomes (6)
Procedure Safety (PS)
This will be assessed at exit from the procedure room and is defined as freedom from procedural mortality, unplanned surgical or interventional procedures related to the Tendyne valve or access procedure.
Measured: Day 0, at exit procedure room
Freedom from LVOT Obstruction (LVOTO) at 30 Days
This will be assessed at 30 days post-procedure and is defined as mean LVOT gradient increase <10 mmHg from baseline (measured by the Echo Core Lab), and free of unplanned intervention for LVOTO.
Measured: At Day 30
Freedom from Paravalvular Leak (PVL) at 30 Days
This will be assessed at 30 days post-procedure and is defined as the Tendyne prosthesis PVL ≤ mild (Grade I), as measured by the Echo Core Lab.
Measured: At Day 30
Left Ventricle Reverse Remodeling at 1 Year
This will be assessed at 1-year post-procedure and is defined as the proportion of survivors at one year with baseline Left Ventricle End Diastolic Volume Index (LVEDVi) > 96ml/m2 that experience 10% or greater reduction in LVEDVi at one year (assessed by the Echo Core lab).
Measured: At 1 Year
All-Cause Mortality at 30 Days
This will be assessed at 30 days post-procedure and is defined as the proportion of subjects who die within 30 days post-procedure for any cause.
Measured: At Day 30
Long-term Device Durability (LDD) at 5 Years
This will be assessed at 5 years post-procedure and is defined as original Tendyne device remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and free from Structural Valve Dysfunction
Measured: At 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start4 May 2021
- Primary completion4 Apr 2024
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818502
- Sponsor's protocol ID
- ABT-CIP-10313
- Acronym
- RESOLVE-MR
- Status last verified
- May 2026
- First submitted
- 22 Mar 2021
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)
- ClinicalTrials.gov ID
- NCT04818502
- Acronym / sponsor ID
- RESOLVE-MR / ABT-CIP-10313
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Tendyne, Tendyne Mitral Valve System, Transcatheter, Mitral Regurgitation, Heart Valve disease, Mitral Valve Regurgitation, Mitral Insufficiency, Transcatheter intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 26 Mar 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.
To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.
Detailed description
The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.
The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of all genders from the population of patients meeting indications for a Tendyne implant as stated within the IFU. Subjects must meet all eligibility criteria and provide written informed consent.
Key inclusion criteria (3 listed)
- Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
- Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
- Patient provides written informed consent prior to any study-specific procedure.
Key exclusion criteria (4 listed)
- Patient is in another clinical study that may impact the follow-up or results of this study.
- Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
- Patient is under the age of 18 or age of legal consent.
- Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
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 SystemAlso: Transcatheter Mitral Valve Implantation (TMVI)Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve. | Device | – |
Primary outcome
Primary Endpoint for MR Elimination at 1 Year
Time frame: At 1 year
The primary endpoint MR Elimination will be assessed at one year post-procedure and is defined as original Tendyne valve remains implanted, free from surgical removal/replacement or transcatheter mitral valve implantation (valve-in-valve), and MR < Grade I (mild, measured by Echocardiographic Core Lab)
6 secondary outcomes
Procedure Safety (PS)
Time frame: Day 0, at exit procedure room
Freedom from LVOT Obstruction (LVOTO) at 30 Days
Time frame: At Day 30
Freedom from Paravalvular Leak (PVL) at 30 Days
Time frame: At Day 30
Left Ventricle Reverse Remodeling at 1 Year
Time frame: At 1 Year
All-Cause Mortality at 30 Days
Time frame: At Day 30
Long-term Device Durability (LDD) at 5 Years
Time frame: At 5 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 28 May 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Regurgitation, run by Abbott Medical Devices at 36 sites in 13 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 4 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, France, Czechia, Italy, Saudi Arabia and 8 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?
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?
Primary Endpoint for MR Elimination at 1 Year (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.