Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease

NCT02173860 | Unknown DMC

• 1 other identifier: SAVEIT351
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease; Valvular Heart Disease

Keywords

Coronary artery disease; Valvular heart disease; Fractional flow reserve; Coronary artery bypass surgery; Coronary graft failure or patency

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• MACCE

  1 month

• MACCE

  6 months

Other Outcomes (12)

• Post operative atrial fibrillation rate

  Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks

• Post operative ICU stay

  participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks

• Hospitalization period

  expected average of ten days

Study Arms (2)

FFR-guided revascularization

ACTIVE COMPARATOR

Patients with valvular heart disease scheduled for elective cardiac surgery and concomitant significant coronary artery disease will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions in vessels pre-specified as suitable for surgical revascularization. If the FFR is ≤0.80, then CABG will be performed. If the FFR is \>0.80 then no graft will be placed in that particular vessel. Patients in whom FFR of a particular lesion is not possible can be included if at least one additional lesion is suitable for FFR measurement and grafting.

Procedure: FFR-guided surgical revascularization

Angio-guided revascularization

ACTIVE COMPARATOR

Concomitant CABG will be performed as per clinical routine in all vessels with at least one stenosis \> 50%. The vessel should be pre-specified as suitable for surgical revascularization before randomization. An internal mammary graft to the LAD should be attempted in all cases, if possible. Further revascularization strategy is left to the discretion of each center.

Procedure: Angio-guided surgical revascularization

Interventions

FFR-guided surgical revascularization PROCEDURE

Also known as: Fractional Flow Reserve-Guided surgical revascularization

FFR-guided revascularization

Angio-guided surgical revascularization PROCEDURE

Also known as: Coronary artery bypass graft guided by angiographic-only assessment of severity stenosis

Angio-guided revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portuguese Society of Cardiology: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Hospital Santa Marta, centro Hospitalar Lisboa Central

Lisbon, Lisbon District, 1169-024, Portugal

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ruben Ramos, MD

  Hospital Santa Marta, Centro Hospitalar Lisboa Central

  PRINCIPAL INVESTIGATOR

• Sergio Batista, MD

  Hospital Fernando da Fonseca

  PRINCIPAL INVESTIGATOR

• Luis Raposo, MD

  Hospital de Santa Cruz, Centro Hospitalar de Lisboa Central

  PRINCIPAL INVESTIGATOR

• Emanuele Barbato, PhD

  Olzv-Aalst Clinic

  PRINCIPAL INVESTIGATOR

• Colin Berry, PhD

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Ramos, MD

CONTACT

+351963156910; ruben.a.b.ramos@gmail.com

Mafalda Selas, RN

CONTACT

+351213594000

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

PT (1)