N/A
N=18
Medtronic CoreValve REDO Study
Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01051310 ↗Enrolled (actual)
18
Serious AEs
83.3%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of MAE Free Subjects — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medtronic CoreValve System (Device)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of MAE Free Subjects |
10 | — |
| PRIMARY Technical Success. |
17 | — |
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:
- Left ventricular ejection fraction (LVEF) 6 month duration) atrial fibrillation,
- Cirrhosis of the liver (Child class A or B),
- Respiratory impairment (FEV1 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.
Data sourced from ClinicalTrials.gov (NCT01051310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.