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Tendyne European Experience Registry

ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLMU Klinikum

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients not providing written informed consent

Trial population

All consecutive patients undergoing Implantation of Tendyne Mitral Valve System at the participating centres.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tendyne Mitral Valve System

    Device

    Tendyne Mitral Valve System for mitral valve disease in a commercial setting

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Tendyne1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

Rate of peri-procedural myocardial infarction

Myocardial infarction during the index procedure

Time frame
1 day
2

Rate of conversion to open-heart surgery

Conversion to open-heart surgery during the index procedure

Time frame
1 day
3

Rate of cardiac tamponade

Cardiac Tamponade during the index procedure

Time frame
1 day
4

Rate of procedural mortality

Death during the index procedure

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LMU Klinikum

Lead sponsor

Source ClinicalTrials.gov
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