REpositionable Versus BallOOn-expandable Prosthesis for T... | NCT02668484

Studies
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

NCT02668484

Sponsor

LMU Klinikum

Status

Completed

Last Update Posted

Jun 3, 2019Actual

Enrollment

116Actual

Phase

Not Applicable

Conditions

Aortic Valve Disease

Interventions

repositionable valve prosthesis
balloon-expandable valve prosthesis

Countries

Germany
Italy

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

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Jan 26, 2016

First Submission Date that Met QC Criteria

Jan 26, 2016

First Posted Date

Jan 29, 2016Estimated

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

May 31, 2019

Last Update Posted Date

Jun 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.

Detailed Description

Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.

The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
repositionable valve prosthesis	Experimental	Lotus	Device: repositionable valve prosthesis
balloon-expandable valve prosthesis	Active Comparator	Sapien	Device: balloon-expandable valve prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
repositionable valve prosthesis	Device	repositionable valve prosthesis implanted via trans-femoral and trans-catheter route	repositionable valve prosthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of new permanent pacemaker implantation	implantation of PM	30 days

Secondary Outcomes

Measure	Description	Time Frame
incidence of any prosthesis regurgitation	prosthesis regurgitation in echocardiography	30 days
Incidence of any conduction abnormalities	conduction abnormalities on rest ECG

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic aortic valve disease in need of valve replacement
Heart team (including at least a cardiac surgeon and an interventional cardiologist) agrees on the eligibility that trans-femoral TAVI is appropriate.
Study patient is an adult of legal consent age.
Study patient has provided written informed consent to participate in the study

Exclusion Criteria:

Life expectancy < 12 months due to co-morbid conditions.
Native aortic valve annulus size and morphology not suitable for Lotus or Sapien prosthesis implantation
Preexisting bioprosthetic valve or ring in aortic valve position.
Pre-existing pacemaker or ICD/CRT.
Cardiogenic shock or hemodynamic instability.
History of active endocarditis
Contraindications for a trans-femoral access.
Severe left ventricular dysfunction with LVEF <30%.
Severe mitral valve insufficiency.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period.
Patients suffering from dementia.
Pregnant or nursing women

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julinda Mehilli, MD	Munich University Clinic, Ludwig-Maximilians University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Munich University Clinic, Ludwig-Maximilians University		Munich	Bavaria	81377	Germany
Segeberger Kliniken Gmbh

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

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases