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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02173860
Other study ID # SAVEIT351
Secondary ID
Status Recruiting
Phase N/A
First received June 19, 2014
Last updated October 20, 2016
Start date July 2016
Est. completion date August 2021

Study information

Verified date October 2016
Source Portuguese Society of Cardiology
Contact Ruben Ramos, MD
Phone +351963156910
Email ruben.a.b.ramos@gmail.com
Is FDA regulated No
Health authority Portugal: Ethics Committee for Clinical Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety outcomes


Description:

The SAVE-IT trial is a multicenter, international, randomized, controlled, superiority trial. Patients scheduled to undergo elective valvular heart surgery will be screened for presence of concomitant coronary artery disease (CAD) by invasive coronary angiography. Patients with a stenosis > 50% in at least one epicardial vessel (excluding left main) considered suitable for surgical revascularization will be randomized to FFR guided- or standard angiography-guided surgical revascularization. A proportion of patients with no concomitant CAD will be followed in a parallel registry

Baseline clinical, laboratory, electrocardiographic and echocardiographic data will be obtained. Coronary anatomy severity will be assessed by quantitative coronary angiography (QCA) and Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (Syntax) score. Surgical risk will be assessed by Euroscore. Patients randomized to FFR-guided arm will have functional severity of the angiographic stenosis assessed by a St. Jude Medical coronary pressure wire measurement under hyperemic conditions using intravenous or intracoronary adenosine administration. If the FFR is ≤0.8 then a graft will be placed distal to the coronary stenosis. If the FFR is >0.8 no grafting will be performed to the epicardial vessel containing the stenosis. Patients will receive cardiac surgery no later than 8 weeks after randomization.

Peri-operative data will be collected. Clinical follow-up data will be collected at 1, 6 and 12 month after surgery. Graft patency at 12 months will be assessed by cardiac computed angiography (CCTA) for all patients who received at least one graft, except if an invasive coronary angiography has been performed in the preceding 3 months based on clinical grounds.


Recruitment information / eligibility

Status Recruiting
Enrollment 502
Est. completion date August 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
FFR-guided surgical revascularization

Angio-guided surgical revascularization


Locations

Country Name City State
Portugal Hospital Santa Marta, centro Hospitalar Lisboa Central Lisbon

Sponsors (2)

Lead Sponsor Collaborator
Portuguese Society of Cardiology St. Jude Medical

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Post operative atrial fibrillation rate Occurrence of any documented episode of symptomatic or asymptomatic episode of atrial fibrillation Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks No
Other Post operative ICU stay From cardiac surgery end to transfer to intermediate care unit or ward. Measured in hours. participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks No
Other Hospitalization period From cardiac surgery to hospital discharge. Measured in days.From date of cardiac surgery until the date of first hospital discharge assessed up to 8 weeks expected average of ten days No
Other Total circulatory bypass time measured in minutes expected maximum of 300 minutes No
Other Total cross-clamp time measured in minutes expected maximum of 300 minutes No
Other Acute renal injury Percentage decline in glomerular filtration rate at post-operative day 4 as compared to pre-operative glomerular filtration rate to post-operative day 4 No
Other Blood transfusion Number of units of red blood cells transfused. participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks No
Other Duration of mechanical ventilation Total duration of mechanical ventilatory support. Repeated intubation will be included participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks No
Other Time to inotropic weaning Total time spent with inotropic support. Recurrent use will be quantified participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks No
Other Use of intra-aortic balloon pump (IABP) Number of patients requiring mechanical hemodynamic support with IABP participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks Yes
Other Anginal status Symptomatic status as defined canadian cardiac society (CCS) anginal status score 12 months No
Other Heart failure symptoms Symptomatic status as defined per New York Heart Association (NYHA) score 12 months No
Primary MACCE Composite endpoint of death, nonfatal myocardial infarction, unplanned revascularization and stroke at 12 months. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity. 12 months No
Primary Graft failure Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated. 12 months No
Secondary MACCE death, nonfatal myocardial infarction, unplanned revascularization and stroke 1 month Yes
Secondary MACCE death, nonfatal myocardial infarction, unplanned revascularization and stroke 6 months No
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