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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT02173860 |
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Date of registration:
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19/06/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease
SAVE-IT |
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Scientific title:
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Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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502 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02173860 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Luis Raposo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Santa Cruz, Centro Hospitalar de Lisboa Central |
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Name:
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Ruben Ramos, MD |
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Address:
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Telephone:
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+351963156910 |
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Email:
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ruben.a.b.ramos@gmail.com |
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Affiliation:
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Name:
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Sergio Batista, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Fernando da Fonseca |
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Name:
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Ruben Ramos, MD |
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Address:
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Telephone:
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+351963156910 |
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Email:
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ruben.a.b.ramos@gmail.com |
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Affiliation:
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Name:
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Colin Berry, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Golden Jubilee National Hospital |
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Name:
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Ruben Ramos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Santa Marta, Centro Hospitalar Lisboa Central |
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Name:
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Emanuele Barbato, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Olzv-Aalst Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years
- Severe heart valve disease with indication for an elective cardiac with a St. Jude
Medical Heart Valve
- Concomitant significant CAD (at least one epicardial vessel with a stenosis> 50%)
- Willing and able to provide informed written consent
Exclusion Criteria:
- Previous CABG
- Angiographic significant lesion involving left main lesion (patient is still eligible
if right coronary artery is candidate for FFR measurement and surgical
revascularization)
- All lesions in extremely tortuous or calcified coronary vessels
- Recent myocardial infarction (< 30 days)
- Cardiogenic shock or clinical instability (i.e. NYHA 4, uncontrolled arrhythmias,
unexplained hypotension severe bradycardia or any other medical condition considered
as a sign of instability by the assisting physician)
- Severe left ventricular dysfunction (EF < 35%)
- Pregnant or are planning to become pregnant during the duration of the investigation
- Chronic renal dysfunction as defined as estimated glomerular filtration rate < 60
ml/min
- Life expectancy < 12 months
- Currently participating in any other clinical investigation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Valvular Heart Disease
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Intervention(s)
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Procedure: Angio-guided surgical revascularization
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Procedure: FFR-guided surgical revascularization
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Primary Outcome(s)
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Graft failure
[Time Frame: 12 months]
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MACCE
[Time Frame: 12 months]
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Secondary Outcome(s)
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MACCE
[Time Frame: 6 months]
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MACCE
[Time Frame: 1 month]
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Secondary ID(s)
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SAVEIT351
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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