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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01676727
Other study ID # Advance-DA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2012
Est. completion date August 2015

Study information

Verified date August 2018
Source Medtronic Cardiovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.


Description:

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2015
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

1. Severe symptomatic aortic valve stenosis requiring treatment

2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use

3. 21 years of age or older

4. Patient is willing and able to comply with all protocol-specified follow-up evaluations

5. The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

6. Patient will receive the CoreValve® device via direct aortic approach TAVI -

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated

2. Sepsis, including active endocarditis

3. Recent myocardial infarction (<30 days)

4. Left ventricular or atrial thrombus by echocardiography

5. Uncontrolled atrial fibrillation

6. Mitral or tricuspid valvular insufficiency (>grade II)

7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)

8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA)

9. Patients with:

1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or

2. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or

3. Thoracic aortic aneurysm in the path of delivery system

10. Bleeding diathesis or coagulopathy

11. Patient refuses blood transfusion

12. Estimated life expectancy of less than 12 months unless TAVI is performed

13. Creatine clearance <20 mL/min

14. Active gastritis or peptic ulcer disease

15. Pregnancy or intent to become pregnant during study follow up

16. Patient is participating in another trial that may influence the results of this study

Study Design


Intervention

Device:
CoreValve aortic valve
Implantation of CoreValve aortic valve via direct aortic approach

Locations

Country Name City State
Czechia Nemocnice Podlesi Trinec Trinec
France Hopital de Rangueil Toulouse
Germany Universitätsklinikum Halle (Saale) Halle (Saale)
Italy Azienda spedaliera Spedali Civili Di Brescia Brescia
Italy Azienda spedaliera Niguarda Ca' Granda Milano Milano
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Medisch centrum Leeuwarden Leeuwarden
United Kingdom Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital Brighton
United Kingdom Royal Brompton & Harefield NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Czechia,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause Mortality Kaplan-Meier estimate of 30-day all-cause mortality. 30 days post-implant
Secondary Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) The combined safety endpoint is defined as a composite of:
All-cause mortality
All stroke
Life-threatening bleeding
Acute kidney injury-Stage 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
High degree AV block requiring permanent pacemaker implantation
1, 6 and 12 months
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