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Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Medtronic CoreValve System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CoreValve

Arm Description

Outcomes

Primary Outcome Measures

Composite Major Adverse Event (MAE) Free Rate

Percentage of subjects without a composite major adverse event (MAE) at 30 (+ 7) days post-procedure. MAE included all-cause death, non-fatal myocardial infarction, stroke, emergent cardiac re-intervention, cardiac tamponade, non-structural or structural valve dysfunction, cardiogenic shock, endocarditis, TIA, embolism, aortic dissection, access site vessel dissection, vessel perforation, acute vessel occlusion, major bleeding and major vascular injury.

Secondary Outcome Measures

Composite Technical Device Success

Composite technical success was defined as the percentage of subjects in whom success on all four technical measures of the "Device Functionality Assessment" was achieved and who were adjudicated as having no device failure or malfunction. The four measures of the ''Device Functionality Assessment'' were: Load the valve delivery system using the loading system Access the aortic valve with the delivery catheter Deploy the valve accurately across the native aortic valve Remove the intact delivery system

Full Information

NCT ID

NCT01051518

First Posted

January 15, 2010

Last Updated

February 18, 2019

Sponsor

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01051518

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CoreValve

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Medtronic CoreValve System

Other Intervention Name(s)

Medtronic CoreValve Trancatheter Aortic Valve, Medtronic CoreValve Percutaneous Aortic Valve

Intervention Description

Transcatheter Aortic Valve

Primary Outcome Measure Information:

Title

Composite Major Adverse Event (MAE) Free Rate

Description

Time Frame

30 (+7) days post procedure

Secondary Outcome Measure Information:

Title

Composite Technical Device Success

Description

Time Frame

Was assessed during the procedure and completed once the procedure was conlcluded

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: Cirrhosis of the liver (Child class A or B), Pulmonary insufficiency : Forced expiratory volume in one second (FEV1) < 1 liter, Previous cardiac surgery (Coronary artery bypass grafting (CABG), valvular surgery), Pulmonary hypertension > 60 mmHg and high risk of cardiac surgery other than valve replacement, Porcelain aorta Recurrent pulmonary embolus, Right ventricular insufficiency, Thoracic burning sequelae contraindicating open chest surgery, History of mediastinum radiotherapy, Severe connective tissue disease resulting in a contraindication to surgery, 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: Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make insertion and endovascular access to the aortic valve impossible, or Symptomatic carotid or vertebral arteries narrowing (> 70%) disease, or 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.

Overall Study Officials: