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New imaging tool could make heart bypass safer during valve surgery

NCT ID NCT03977129

Knowledge-focused Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two methods for deciding which blocked heart arteries need bypass during valve surgery. The standard method uses angiography (X-ray dye), while the new method uses a computer calculation called QFR. About 792 patients will be randomly assigned to one method, and researchers will track major complications like death, heart attack, or stroke within 30 days after surgery. The goal is to see if QFR leads to fewer problems by more accurately identifying which blockages truly need treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quantitative Flow Ratio (QFR) imaging software
What this could lead to
If successful, this could show that using QFR to decide which blocked arteries need bypass during valve surgery reduces complications like heart attack or stroke within 30 days.
What could go wrong
This is a mid-stage study with 792 patients, but it only looks at short-term outcomes (30 days). The results may not apply to all patients or long-term benefits, and the new method might not be better than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

792 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder heart valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease Primary valvular heart disease with comorbid coronary artery disease

Contacts and locations

Locations

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The Second XiangYa Hospital of Central South University

    Changsha, Hunan, China

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, China

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