Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

ConditionAortic Valve Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Luebeck

About this trial

Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement

BMI <35 kg/m2

Ability to give informed consent

Disqualifiers

History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)

Age ≤18 years

Patients presenting with pregnancy

Patients without informed consent

Trial population

Patients who were treated with Myval TAVR via TAX access are included in the registry. The participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT/3/Ultra, Medtronic Evolut R/Pro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate/severe axillary tortuosity and moderate/severe axillary, calcification).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

transaxillary (TAX) transcatheter aortic valve replacement
Other intervention
Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Time until first occurrence

* Stroke including ischemic or hemorrhagic stroke, * Systemic embolism, * Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death

Time frame

30 Days

Sponsors and contacts

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

University of Luebeck

Lead sponsor

University Hopsital Schleswig Holstein Campus Lübeck

Collaborator

Source ClinicalTrials.gov

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