Aortic Valve StenosisREDONCT01051310
Medtronic CoreValve REDO Study
A study testing Medtronic CoreValve System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Medtronic CoreValve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 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:
- Left ventricular ejection fraction (LVEF) < 20%,
- Creatinine clearance < 20mL/min (estimation using the Cockcroft calculation),
Show all 20Show fewer
- Renal failure requiring dialysis,
- Permanent and long lasting (> 6 month duration) atrial fibrillation,
- Cirrhosis of the liver (Child class A or B),
- Respiratory impairment (FEV1 < 1L),
- 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),
- Pulmonary hypertension ³ 60mmHg,
- Recurrent pulmonary embolus,
- Moderate tricuspid (< grade 2+) insufficiency,
- Any severe disease contraindicating surgery,
- Calcified aorta (porcelain aorta),
- Recent myocardial infarction (less than 30 days at baseline),
- 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.
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Herzzentrum Leipzig GmbH
Leipzig
Deutsches Herzzentrum München
München
About this 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
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:
Read more
- 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Medtronic CoreValve System
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic CoreValve SystemDevice
Also called Medtronic CoreValve Transcatheter aortic valve, Medtronic CoreValve Percutaneous aortic valve
Transcatheter Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| CoreValve | Experimental | Not described Receives: Device: Medtronic CoreValve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of MAE Free Subjects
Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes:
- MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement.
- MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure.
Measured: 30 days post-procedure
Technical Success.
The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Grube, Prof. Dr., Principal investigator, Helios Heart Center Siegburg, GermanyG. Schuler, Prof. Dr., Principal investigator, Universitat Leipzig Herzzentrum, GermanyR. Lange, Prof. Dr., Principal investigator, Deutsches Herzzentrum Munich, GermanyP. de Jaegere, Dr., Principal investigator, Erasmus MC Rotterdam, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051310
- Sponsor's protocol ID
- COR-2007-03
- Acronym
- REDO
- Status last verified
- Aug 2018
- First submitted
- 15 Jan 2010
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01051310
- Acronym / sponsor ID
- REDO / COR-2007-03
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreValve | Experimental | Device: Medtronic CoreValve System |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- > 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:
- Inner diameter of the failing bioprosthetic aortic valve (homograft or stented or stentless heterograft) of ³ 19mm and < 26mm as determined by Doppler echocardiography,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic CoreValve SystemAlso: Medtronic CoreValve Transcatheter aortic valve, Medtronic CoreValve Percutaneous aortic valveTranscatheter Aortic Valve | Device | CoreValve |
Primary outcome
Percentage of MAE Free Subjects
Time frame: 30 days post-procedure
Percentage of subjects without a composite major adverse event (MAE) at 30 days post procedure. the composite MAE includes: 1. MACCE (Major Adverse Cardiac or Cerebral Event): cardiac death, documented Mobitz type II second degree and third degree atrioventricular block, neurological events and surgical aortic valve replacement. 2. MAE: non cardiac death including sudden unexpected or unexplained death, cardiac tamponade, nonstructural valve dysfunction resulting in stenosis or regurgitation at the study valve not intrinsic to the valve itself, structural valve deterioration cardiogenic shock, operated valve endocarditis, valve thrombosis, aortic dissection/perforation, major bleeding event, peripheral embolic event and emergent revascularization procedure.
Technical Success.
Time frame: 30 days post procedure
The number of subjects in whom technical success was achieved where technical success was defined based on the device functionality as judged by the investigator adressing the ability of the system (1) to access the failing bioprosthetic valve via a peripheral vessel with the delivery catheter and (2) to deploy the valve accurately across the failing bioprosthetic valve and (3) to remove intact delivery system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Aortic Valve Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Grube, Prof. Dr. principal investigator
Helios Heart Center Siegburg, Germany
G. Schuler, Prof. Dr. principal investigator
Universitat Leipzig Herzzentrum, Germany
R. Lange, Prof. Dr. principal investigator
Deutsches Herzzentrum Munich, Germany
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic CoreValve System in people with Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of MAE Free Subjects (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.