Clinical trial NCT01051310: Medtronic CoreValve REDO Study
Official title: Feasibility Study of Percutaneous Aortic Valve Implantation With the Medtronic CoreValve System for Percutaneous Aortic Valve Replacement (PAVR) in Patients With a Failing Previously Surgically Implanted Aortic Bioprosthesis and Presenting a High Risk for Repeat Surgical Valve Replacement
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: 18
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 proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure.

These objectives will be achieved through the following endpoints:

* Primary safety endpoint - Composite of Major Adverse Events
* Primary performance endpoint - Technical and procedural success at discharge

Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.


Eligibility criteria: Inclusion Criteria:

* \> 74 years old,
* Symptomatic failing bioprosthetic aortic valve (stenotic, incompetent or mixed) confirmed by Doppler echocardiography,
* Logistic EuroSCORE \> 15%, or
* Any of the following criteria:

  1. Left ventricular ejection fraction (LVEF) \< 20%,
  2. Creatinine clearance \< 20mL/min (estimation using the Cockcroft calculation),
  3. Renal failure requiring dialysis,
  4. Permanent and long lasting (\> 6 month duration) atrial fibrillation,
  5. Cirrhosis of the liver (Child class A or B),
  6. Respiratory impairment (FEV1 \< 1L),
  7. Previous cardiac surgery (i.e., CABG especially if patient had competent mammary arteries on left anterior descending (LAD) artery or occluded saphenous veins with high-risk of coronary embolism during re-operation),
  8. Pulmonary hypertension ³ 60mmHg,
  9. Recurrent pulmonary embolus,
  10. Moderate tricuspid (\< grade 2+) insufficiency,
  11. Any severe disease contraindicating surgery,
  12. Calcified aorta (porcelain aorta),
  13. Recent myocardial infarction (less than 30 days at baseline),
  14. Contraindication for cardiopulmonary bypass,
* Inner diameter of the failing bioprosthetic aortic valve (homograft or stented or stentless heterograft) of ³ 19mm and \< 26mm as determined by Doppler echocardiography,
* Signed informed consent form.

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine and clopidogrel, Nitinol, or sensitivity to contrast media which cannot be pre-medicated,
* Active infection or endocarditis,
* Any intra left ventricular mass, thrombus or vegetation evidenced by Doppler echocardiography,
* Mitral or tricuspid valvular insufficiency ³ grade 2+,
* Prosthetic mitral or tricuspid valve,
* Femoral and/or iliac and/or aortic vascular condition (stenosis, occlusion or tortuosity) that could complicate endovascular access to the aortic valve bioprosthesis,
* Symptomatic carotid or vertebral artery narrowing (\> 70%) disease,
* Aortic abdominal or thoracic aneurysm,
* Bleeding diathesis or coagulopathy, or patient refuses blood transfusion,
* Active peptic ulcer or has had upper gastrointestinal bleeding within the past 3 months before baseline,
* Moribund status or cachexia with short life-expectancy independent of cardiac condition,
* Any acute neurological event or dysfunction occurred in the past 6 weeks before baseline or patient with severe senile dementia,
* Therapeutic invasive cardiac procedure, other than balloon aortic valvuloplasty, performed within 30 days prior to study procedure or to be performed during or within 30 days after the study procedure,
* Currently, enrolled in this study or another investigational drug or device study.

Primary outcomes:
measure: Percentage of MAE Free Subjects
timeFrame: 30 days post-procedure
measure: Technical Success.
timeFrame: 30 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Helios Heart Center Siegburg, Germany
name: E. Grube, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Leipzig Herzzentrum, Germany
name: G. Schuler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum Munich, Germany
name: R. Lange, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC Rotterdam, Netherlands
name: P. de Jaegere, Dr.
role: PRINCIPAL_INVESTIGATOR
References: