Clinical trial NCT01051518: Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
Official title: Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 126
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.

Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.


Eligibility criteria: Inclusion Criteria:

* Native aortic valve disease, defined as valve stenosis with an aortic valve area \<1cm² (\<0.6cm2/m2) as determined by echocardiographic measure,
* ≥ 75 years, or
* Surgical risk calculated with logistic EuroSCORE ≥ 15 %, or
* One or two (but not more than 2) of the following complicating factors:

  1. Cirrhosis of the liver (Child class A or B),
  2. Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) \< 1 liter,
  3. Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery),
  4. Pulmonary hypertension \> 60 mmHg and high risk of cardiac surgery other than valve replacement,
  5. Porcelain aorta
  6. Recurrent pulmonary embolus,
  7. Right ventricular insufficiency,
  8. Thoracic burning sequelae contraindicating open chest surgery,
  9. History of mediastinum radiotherapy,
  10. Severe connective tissue disease resulting in a contraindication to surgery,
  11. Cachexia (BMI ≤ 18 kg/m²),
* Aortic valve annulus diameter is ≥ 20 mm and ≤ 27 mm as determined by echocardiographic measure,
* Ascending aorta diameter £ 45 mm at the sino-tubular junction, and
* Signed Informed Consent.

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated,
* Any sepsis, including active endocarditis,
* Recent myocardial infarction (\< 30 days),
* Percutaneous coronary or vascular intervention within 15 days prior to the study procedure, or scheduled during or within 30 days after the study procedure,
* Any left ventricular or atrial thrombus diagnosed by echocardiography,
* Uncontrolled atrial fibrillation (heart rate greater than 100 bpm),
* Mitral or tricuspid valvular insufficiency ( \> grade II),
* Previous aortic valve replacement (mechanical valve OR stented bioprosthetic valve),
* Any condition considered as contraindication for extracorporeal assistance,
* Evolutive or recent CVA (cerebro vascular accident),
* Poly arterial patients with either:

  1. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or
  2. Symptomatic carotid or vertebral arteries narrowing (\> 70%) disease, or
  3. Abdominal or thoracic aortic aneurysm,
* Bleeding diathesis or coagulopathy, or patient who will refuse blood transfusion,
* Evolutive disease with life expectancy less than one year,
* Creatinine clearance \< 20 ml/min,
* Pregnancy, and
* Enrolled in another investigational study.

Primary outcomes:
measure: Composite Major Adverse Event (MAE) Free Rate
timeFrame: 30 (+7) days post procedure
Secondary outcomes:
measure: Composite Technical Device Success
timeFrame: Was assessed during the procedure and completed once the procedure was conlcluded
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Siegburg
country: Germany
facility: HELIOS Heart Center Siegburg
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Trust
Study officials:
affiliation: Helios Heart Center Siegburg, Germany
name: E. Grube, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum Universitat Leipzig, Germany
name: G. Schuler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cardiologie de Montreal, Canada
name: R. Bonan, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Glenfield Hospital Leicester, UK
name: J. Kovac, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC Rotterdam, Netherlands
name: P. Serruys, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa Heart Institute, Canada
name: M. Labinaz, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Amphia Hospital Breda, Netherlands
name: P den Heijer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton & Harefield NHS Trust London, UK
name: M Mullen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta Hospital, Canada
name: W. Tymchak, Dr.
role: PRINCIPAL_INVESTIGATOR
References: