Study Stopped
By recommendation from the Data and safety monitoring board
Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
Randomized Comparison of Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis
1 other identifier
interventional
72
1 country
1
Brief Summary
This study is a randomised comparison of apical stent valve treatment versus conventional valve surgery in patients with severe aortic valve stenosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 1, 2017
May 1, 2017
2.3 years
September 25, 2009
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death, CVI and/or renal failure requiring any dialysis
1 month
Secondary Outcomes (1)
Echocardiographic results, valve performance
1 month with subseguent followup
Study Arms (2)
Conventional Aortic Valve Surgery
ACTIVE COMPARATORInsertion of a biological valve
Transapical Aortic Valve Implantation
EXPERIMENTALTransapical implantation of an Edwards SAPIENtm valve
Interventions
Insertion of a stent valve using catheter-based technique through a mini thoracotomy
Operation using heart-lung machine, with insertion of a biological artificial heart valve
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospital Skejbylead
- Odense University Hospitalcollaborator
- Danish Heart Foundationcollaborator
Study Sites (1)
Aarhus University Hospital, Skejby
Aarhus N, Central Jutland, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evald H Christiansen, MD
Skejby Hospital, Aarhus, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 29, 2009
Study Start
December 1, 2008
Primary Completion
April 1, 2011
Study Completion
April 1, 2016
Last Updated
June 1, 2017
Record last verified: 2017-05