MYVAL Transcatheter Heart Valve System - Prospective Germ... | NCT06804148

Studies
MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

NCT06804148

Sponsor

Prof. Dr. med. Ingo Eitel

Status

Recruiting

Last Update Posted

Feb 3, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Myval Transcatheter Heart Valve

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 30, 2030Estimated

First Submitted Date

Jan 27, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Feb 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2025

Last Update Posted Date

Feb 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. med. Ingo Eitel, Head of department of medical clinic II, University of LuebeckSponsor-Investigator

Lead Sponsor

Prof. Dr. med. Ingo EitelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myval Transcatheter Heart Valve	Device	The Myval TAVR bioprothesis is a balloon-expandable THV developed by Meril Lifesciences, which has novel operator friendly design features to improve deliverability and aid precise deployment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation		5 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is going to be treated with Myval THV
Age ≥ 18 years
Ability to give informed consent

Exclusion Criteria:

Pregnant and lactating women
Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who will be treated with Myval TAVR are included in the registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ingo Eitel, Prof. Dr.	Contact	004945150044542		cvro@uksh.de
Christian Frerker, PD Dr.	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Schleswig-Holstein - Campus Lübeck	Recruiting	Lübeck	Schleswig-Holstein	23538	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided