Transapical Transcatheter Treatment Versus Conventional S... | NCT00986193

Studies
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis

NCT00986193

Sponsor

Aarhus University Hospital Skejby

Status

Terminated

Last Update Posted

Jun 1, 2017Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Aortic Valve Stenosis

Interventions

Transapical Aortic Valve Implantation
Conventional Aortic Valve Surgery

Countries

Denmark

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 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

By recommendation from the Data and safety monitoring board

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2016Actual

First Submitted Date

Sep 25, 2009

First Submission Date that Met QC Criteria

Sep 28, 2009

First Posted Date

Sep 29, 2009Estimated

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, 2017

Last Update Posted Date

Jun 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Evald Hoej Christiansen, MD, Aarhus University Hospital SkejbyPrincipal Investigator

Lead Sponsor

Aarhus University Hospital SkejbyOTHER

Collaborators

Name	Class
Odense University Hospital	OTHER
Danish Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.

Detailed Description

The purpose of the study is to compare the new established apical stent valve treatment with conventional surgical intervention using biological valve prostheses in patients with severe aortic valve stenosis.

The Edwards-SAPIENTM Transcatheter Heart Valve (Edwards Lifesciences, Irvine, CA) will be used in the stent valve group. The Carpentier-Edwards-Perimount Heart Valve (Edwards Lifesciences, Irvine, CA) will be recommended for the conventional surgery group.(Edwards Lifesciences, Irvine, CA).

Heart centres in the Nordic region with experience (>10 cases) in apical stent valve treatment and in conventional surgical treatment of high risk patients with aortic valve stenosis. The study will be initiated at Aarhus University Hospital, Skejby, Denmark.

Study hypothesis:

As compared to conventional aortic valve substitution in patients aged >75 years, apical stent valve treatment reduces the rates of death, cerebrovascular insult (CVI) and need of dialysis for renal failure 1 month after the treatment.

Primary clinical end-point:

Combined end-point consisting of death, CVI and/or renal failure with need for haemodialysis, 1 month after index treatment.

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Aortic Valve Surgery	Active Comparator	Insertion of a biological valve	Procedure: Conventional Aortic Valve Surgery
Transapical Aortic Valve Implantation	Experimental	Transapical implantation of an Edwards SAPIENtm valve	Procedure: Transapical Aortic Valve Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transapical Aortic Valve Implantation	Procedure	Insertion of a stent valve using catheter-based technique through a mini thoracotomy	Transapical Aortic Valve Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death, CVI and/or renal failure requiring any dialysis		1 month

Secondary Outcomes

Measure	Description	Time Frame
Echocardiographic results, valve performance		1 month with subseguent followup

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Significant aortic valve stenosis (valve area < 1cm2)
Age > 75 (years Aarhus University Hospital, Skejby)
Age > 80 years (other participating centres)
Operable by conventional surgery AND transapical stent valve implantation
Expected survival > 1 year following successful treatment
Accept of participation and in follow-up investigations after adequate information
Informed consent

Exclusion Criteria:

Coronary artery disease requiring PCI or CABG
Earlier cardiac surgery
Myocardial infarction within 24 hours
Kidney failure requiring any dialysis
Ongoing infection
Acute surgery
Allergy to ASA or Clopidogrel

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evald H Christiansen, MD	Skejby Hospital, Aarhus, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital, Skejby		Aarhus N	Central Jutland	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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