Coronary Bypass Graft StenosisNCT05430568
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
An observational study of Coronary Bypass Graft Stenosis and Valvular Heart Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Bypass Graft Stenosis, Valvular Heart Disease
- What is being tested?
- robot-assisted surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: coronary artery and valvular heart disease patients
Who may be able to join
- patient who undergo surgery for coronary artery bypass graft or valvular replacement.
Who cannot join
- pregnant
- patients who receive more than one type of surgery
- severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
- cannot perform the cardiopulmonary exercise testing
- other contraindications for cardiopulmonary exercise testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Physical Medicine and Rehabilitation
Taichung, Taiwan, 40705
About this study
Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.
Read the detailed description
The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure.
Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial.
Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery.
The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery
- Being tested
- robot-assisted surgery
- Keywords
- cardiorespiratory fitness, robotic assisted surgery, cardiopulmonary exercise testing
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted surgeryProcedure or surgery
Also called sternotomy
- traditional sternotomy for coronary bypass graft or valvular replacement
- robot-assisted surgery for coronary bypass graft or valvular replacement
| Study group | Role | What they receive |
|---|---|---|
| bypass graft, sternotomy | patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure | |
| bypass graft, robot | patients who have received coronary artery bypass graft surgery with robot-assisted procedure Receives: Procedure: robot-assisted surgery | |
| valvular heart disease, sternotomy | patients who have received valvular replacement surgery with conventional sternotomy procedure | |
| valvular heart disease, robot | patients who have received valvular replacement surgery with robot-assisted procedure Receives: Procedure: robot-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal oxygen consumption post-surgery
the change of maximal oxygen consumption from surgery before to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of maximal oxygen consumption in 3 months
the change of maximal oxygen consumption from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Change of anaerobic threshold post surgery
the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of anaerobic threshold in 3 months
the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Change of six minute walking test result post-surgery
the change of six minute walking test result from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of six minute walking test result in 3 months
the change of six minute walking test result from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Secondary outcomes (12)
Change of vital capacity post-surgery
the change of vital capacity during pulmonary function testing from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of vital capacity in 3 months
the change of vital capacity during pulmonary function testing from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Change of respiratory flow post-surgery
the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of respiratory flow ratio in 3 months
the change of the ratio of air volume on exhalation to vital capacity during the first second in the pulmonary function testing from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Change of resting heart rate post-surgery
the change of resting heart rate from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of resting heart rate in 3 months
the change of resting heart rate from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
Change of oxygen pulse post-surgery
the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 2 weeks after surgery
Measured: pre-operation to 2 weeks post-operation
Change of oxygen pulse in 3 months
the change of the maximal value of VO2 divided by heart rate during exercise testing from before surgery to 3 months after surgery
Measured: pre-operation to 3 months post-operation
pain post-surgery
pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 2 weeks after surgery
Measured: 2 weeks post-operation
pain in 3 months
pain visual analog scale score (from 0 to 10, higher score means more painful) for surgery wound pain at 3 months after surgery
Measured: 3 months post-operation
Change of activity status post-surgery
the change of the Duke Activity Status Index (DASI) score from before surgery to 2 weeks after surgery.
The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness.
Measured: pre-operation to 2 weeks post-operation
Change of activity status in 3 months
the change of the Duke Activity Status Index (DASI) score from before surgery to 3 months after surgery The DASI is a score ranging from 0 to 58.2. A higher score indicates a better cardiorespiratory fitness.
Measured: pre-operation to 3 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bypass Graft StenosisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuchun Lee, MD, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430568
- Sponsor's protocol ID
- CE22214A
- Status last verified
- Sep 2025
- First submitted
- 29 May 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT05430568
- Acronym / sponsor ID
- CE22214A
- Keywords
- cardiorespiratory fitness, robotic assisted surgery, cardiopulmonary exercise testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.
Detailed description
The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure.
Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial.
Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery.
The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bypass graft, sternotomy | – | –patients who have received coronary artery bypass graft surgery with conventional sternotomy procedure |
| bypass graft, robot | – | Procedure: robot-assisted surgerypatients who have received coronary artery bypass graft surgery with robot-assisted procedure |
| valvular heart disease, sternotomy | – | –patients who have received valvular replacement surgery with conventional sternotomy procedure |
| valvular heart disease, robot | – | Procedure: robot-assisted surgerypatients who have received valvular replacement surgery with robot-assisted procedure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- coronary artery and valvular heart disease patients
Key inclusion criteria (1 listed)
- patient who undergo surgery for coronary artery bypass graft or valvular replacement.
Key exclusion criteria (5 listed)
- pregnant
- patients who receive more than one type of surgery
- severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
- cannot perform the cardiopulmonary exercise testing
- other contraindications for cardiopulmonary exercise testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot-assisted surgeryAlso: sternotomy1. traditional sternotomy for coronary bypass graft or valvular replacement 2. robot-assisted surgery for coronary bypass graft or valvular replacement | Procedure or surgery | bypass graft, robot, valvular heart disease, robot |
Primary outcome
Change of maximal oxygen consumption post-surgery
Time frame: pre-operation to 2 weeks post-operation
the change of maximal oxygen consumption from surgery before to 2 weeks after surgery
Change of maximal oxygen consumption in 3 months
Time frame: pre-operation to 3 months post-operation
the change of maximal oxygen consumption from before surgery to 3 months after surgery
Change of anaerobic threshold post surgery
Time frame: pre-operation to 2 weeks post-operation
the change of the onset of lactate accumulation in blood from before surgery to 2 weeks after surgery
Change of anaerobic threshold in 3 months
Time frame: pre-operation to 3 months post-operation
the change of the onset of lactate accumulation in blood from before surgery to 3 months after surgery
Change of six minute walking test result post-surgery
Time frame: pre-operation to 2 weeks post-operation
the change of six minute walking test result from before surgery to 2 weeks after surgery
Change of six minute walking test result in 3 months
Time frame: pre-operation to 3 months post-operation
the change of six minute walking test result from before surgery to 3 months after surgery
12 secondary outcomes
Change of vital capacity post-surgery
Time frame: pre-operation to 2 weeks post-operation
Change of vital capacity in 3 months
Time frame: pre-operation to 3 months post-operation
Change of respiratory flow post-surgery
Time frame: pre-operation to 2 weeks post-operation
Change of respiratory flow ratio in 3 months
Time frame: pre-operation to 3 months post-operation
Change of resting heart rate post-surgery
Time frame: pre-operation to 2 weeks post-operation
Change of resting heart rate in 3 months
Time frame: pre-operation to 3 months post-operation
Change of oxygen pulse post-surgery
Time frame: pre-operation to 2 weeks post-operation
Change of oxygen pulse in 3 months
Time frame: pre-operation to 3 months post-operation
pain post-surgery
Time frame: 2 weeks post-operation
pain in 3 months
Time frame: 3 months post-operation
Change of activity status post-surgery
Time frame: pre-operation to 2 weeks post-operation
Change of activity status in 3 months
Time frame: pre-operation to 3 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuchun Lee, MD study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bypass Graft Stenosis and Valvular Heart Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchun Lee, MD (886-4-23592525 ext. 3207, lyczoj@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of maximal oxygen consumption post-surgery (time frame: pre-operation to 2 weeks post-operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.