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

NCT01051518 | Completed Results DMC

• 1 other identifier: COR-2006-02
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 9

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  30 (+7) days post procedure

Secondary Outcomes (1)

• Composite Technical Device Success

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

Study Arms (1)

CoreValve

EXPERIMENTAL

Device: Medtronic CoreValve System

Interventions

Medtronic CoreValve System DEVICE

Transcatheter Aortic Valve

Also known as: Medtronic CoreValve Trancatheter Aortic Valve, Medtronic CoreValve Percutaneous Aortic Valve

CoreValve

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

University of Alberta Hospital

Edmonton, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Canada

Location

University of Ottawa Heart Institute

Ottawa, Canada

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

HELIOS Heart Center Siegburg

Siegburg, Germany

Location

Amphia Hospital

Breda, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Glenfield Hospital

Leicester, United Kingdom

Location

Royal Brompton & Harefield NHS Trust

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: M. Hollander
• Organization: Medtronic

maarten.hollander@medtronic.com

+31620534428

Study Officials

• E. Grube, Prof. Dr.

  Helios Heart Center Siegburg, Germany

  PRINCIPAL INVESTIGATOR

• G. Schuler, Prof. Dr.

  Herzzentrum Universitat Leipzig, Germany

  PRINCIPAL INVESTIGATOR

• R. Bonan, Dr.

  Institut de Cardiologie de Montreal, Canada

  PRINCIPAL INVESTIGATOR

• J. Kovac, Dr.

  Glenfield Hospital Leicester, UK

  PRINCIPAL INVESTIGATOR

• P. Serruys, Prof. Dr.

  Erasmus MC Rotterdam, Netherlands

  PRINCIPAL INVESTIGATOR

• M. Labinaz, Dr.

  University of Ottawa Heart Institute, Canada

  PRINCIPAL INVESTIGATOR

• P den Heijer, Dr.

  Amphia Hospital Breda, Netherlands

  PRINCIPAL INVESTIGATOR

• M Mullen, Dr.

  Royal Brompton & Harefield NHS Trust London, UK

  PRINCIPAL INVESTIGATOR

• W. Tymchak, Dr.

  University of Alberta Hospital, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: May 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2013
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

NL (2); GB (2); CA (3); DE (2)