Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease Clinical Trial
— FAVOR4-QVASOfficial title:
A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
| NCT number | NCT03977129 |
| Other study ID # | 2018CR001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 4, 2019 |
| Est. completion date | December 2026 |
This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the incidence of composite outcome (MACE-5, including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the MACE-5 within 30 days after surgery, as compared with the CAG-guided strategy.
| Status | Recruiting |
| Enrollment | 792 |
| Est. completion date | December 2026 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Voluntarily participate in the trial and provide the informed consent form; - Male or female patients aged = 18 years; - Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.); - At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with = 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of = 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization. Exclusion Criteria: - History of heart surgery; - Planned second-stage PCI or CABG revascularization; - Secondary valvular heart disease (ischemia, cardiomyopathy); - Planned valve intervention surgery through the catheter; - Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician; - QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery); - The target coronary arteries were evaluated to be not suitable for CABG by study physician; - Life expectancy < 3 years. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Second XiangYa Hospital of Central South University | Changsha | Hunan |
| China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
| China | The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
| China | Changhai Hospital of Shanghai | Shanghai | Shanghai |
| China | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
| China | Shanghai Chest Hospital | Shanghai | Shanghai |
| China | Tianjin Chest Hospital | Tianjin | Tianjin |
| China | Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital | Med-X Research Institute, Shanghai Jiao Tong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The number of grafts per person | counted as distal anastomosis | at Day 0 | |
| Other | The total circulatory time during the surgery | minutes | at Day 0 | |
| Other | The total cross-clamp time during the surgery | minutes | at Day 0 | |
| Other | The total units of erythrocyte transfusion during and after the surgery till discharge | from Day 0 to discharge day | ||
| Other | The number of days from surgery day to discharge day | from Day 0 to discharge day | ||
| Other | Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4) | at 1 year after surgery | ||
| Other | Change from baseline in the CCS anginal status score (0-4) | at 3 years after surgery | ||
| Other | Change from baseline in the New York Heart Association (NYHA) score (1-4) | at 1 year after surgery | ||
| Other | Change from baseline in the NYHA score (1-4) | at 3 years after surgery | ||
| Primary | The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis | within 30 days after surgery | ||
| Secondary | The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year | The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure | within 1 year after surgery | |
| Secondary | The incidence of 1-year graft failure (stenosis = 50% or occlusion occurred in grafts or distal anastomosis) | at 1 year after surgery | ||
| Secondary | The time from randomization to first occurrence of any of composite outcome (MACE-6) within 3 year | The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure | within 3 years after surgery | |
| Secondary | The incidence of 3-year graft failure (stenosis = 50% or occlusion occurred in grafts or distal anastomosis) | at 3 years after surgery | ||
| Secondary | Health-related quality of life | the variables are the EQ-5D scores | within 30 days, 1 year and 3 years after surgery | |
| Secondary | Cost effectiveness | the variables are the cost increased for each composite outcome reduction at 30 days after surgery and cost increased for each additional QALY at 1 year and 3 years after surgery | within 30 days, 1 year and 3 years after surgery |