AnesthesiaNCT06397092
Anesthetic Management for TA-BSM in HOCM
An observational study of Anesthesia and Transapical Beating-heart Septal Myectomy, run by Tongji Hospital at 1 site in China.
Trial summary
To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Transapical Beating-heart Septal Myectomy, Hypertrophic Cardiomyopathy
- What is being tested?
- transapical beating-heart septal myectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2022 to January 2023 was extracted and screened according to the inclusion criteria and exclusion criteria
Who may be able to join
- Patients with hypertrophic cardiomyopathy
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Undergoing TA-BSM
Who cannot join
- Cardiopulmonary bypass was used to assist the surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, 430030
About this study
Official title: Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)：A Retrospective Analysis
To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.
Read the detailed description
Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.
In order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.
The team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.
Since TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients.
- Being tested
- transapical beating-heart septal myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transapical beating-heart septal myectomyProcedure or surgery
The patients with hypertrophic cardiomyopathy undergoing TA-BSM
| Study group | Role | What they receive |
|---|---|---|
| TA-BSM | The hypertrophic cardiomyopathy patients received TA-BSM Receives: Procedure: transapical beating-heart septal myectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative information 1
Heart reat
Measured: During surgery, when use isoproterenol to provocate
Perioperative information 2
Systolic arterial blood pressure
Measured: During surgery, when use isoproterenol to provocate
Perioperative information 3
Diastolic arterial blood pressure
Measured: During surgery, when use isoproterenol to provocate
Perioperative information 4
Mean arterial blood pressure
Measured: During surgery, when use isoproterenol to provocate
Perioperative information 5
The type of tracheal tube
Measured: Immediately after the surgery
Perioperative information 6
The usage of anaesthetic drugs
Measured: Immediately after the surgery
Perioperative information 7
The usage of cardiovascular drugs
Measured: Immediately after the surgery
Perioperative information 8
Intraoperative infusion volume
Measured: Immediately after the surgery
Perioperative information 9
Blood transfusion volume
Measured: Immediately after the surgery
Perioperative information 10
Blood loss
Measured: Immediately after the surgery
Secondary outcomes (8)
Postoperative information 1
Extubation time,
Measured: Postoperative in 30 days
Postoperative information 2
Postoperative pain score: Pain score evaluation was performed after surgery ( 0-10 stands for the degree of the pain, 0 for painless and 10 for twinge).
Measured: Postoperative in 30 days
Postoperative information 3
The usagen of analgesic drug
Measured: Postoperative in 30 days
Postoperative information 4
Postoperative complications
Measured: Postoperative in 30 days
Laboratory tests information 1
The changes of hemoglobin (Hb)
Measured: 7 days before surgery and 3 days after surgery
Laboratory tests information 2
the changes of creatinine (Cr)
Measured: 7 days before surgery and 3 days after surgery
Laboratory tests information 3
the changes of albumin (Alb)
Measured: 7 days before surgery and 3 days after surgery
Laboratory tests information 4
the changes of cardiac uhrasonography findings
Measured: 7 days before surgery and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Apr 2022
- Primary completion31 Jan 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao (101480), Tongji Hospital
- Investigators
- Wenlong Yao, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397092
- Sponsor's protocol ID
- TongjiHospital-Anes QQ03
- Status last verified
- May 2024
- First submitted
- 7 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)：A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06397092
- Acronym / sponsor ID
- TongjiHospital-Anes QQ03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 2 May 2024 (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.
To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.
Detailed description
Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.
In order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.
The team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.
Since TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TA-BSM | – | Procedure: transapical beating-heart septal myectomyThe hypertrophic cardiomyopathy patients received TA-BSM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2022 to January 2023 was extracted and screened according to the inclusion criteria and exclusion criteria
Key inclusion criteria (3 listed)
- Patients with hypertrophic cardiomyopathy
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Undergoing TA-BSM
Key exclusion criteria (1 listed)
- Cardiopulmonary bypass was used to assist the surgery.
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 |
|---|---|---|
| transapical beating-heart septal myectomyThe patients with hypertrophic cardiomyopathy undergoing TA-BSM | Procedure or surgery | TA-BSM |
Primary outcome
Perioperative information 1
Time frame: During surgery, when use isoproterenol to provocate
Heart reat
Perioperative information 2
Time frame: During surgery, when use isoproterenol to provocate
Systolic arterial blood pressure
Perioperative information 3
Time frame: During surgery, when use isoproterenol to provocate
Diastolic arterial blood pressure
Perioperative information 4
Time frame: During surgery, when use isoproterenol to provocate
Mean arterial blood pressure
Perioperative information 5
Time frame: Immediately after the surgery
The type of tracheal tube
Perioperative information 6
Time frame: Immediately after the surgery
The usage of anaesthetic drugs
Perioperative information 7
Time frame: Immediately after the surgery
The usage of cardiovascular drugs
Perioperative information 8
Time frame: Immediately after the surgery
Intraoperative infusion volume
Perioperative information 9
Time frame: Immediately after the surgery
Blood transfusion volume
Perioperative information 10
Time frame: Immediately after the surgery
Blood loss
8 secondary outcomes
Postoperative information 1
Time frame: Postoperative in 30 days
Postoperative information 2
Time frame: Postoperative in 30 days
Postoperative information 3
Time frame: Postoperative in 30 days
Postoperative information 4
Time frame: Postoperative in 30 days
Laboratory tests information 1
Time frame: 7 days before surgery and 3 days after surgery
Laboratory tests information 2
Time frame: 7 days before surgery and 3 days after surgery
Laboratory tests information 3
Time frame: 7 days before surgery and 3 days after surgery
Laboratory tests information 4
Time frame: 7 days before surgery and 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- 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. This study is not recruiting at the moment.
Wenlong Yao principal investigator
Tongji 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 Anesthesia and Transapical Beating-heart Septal Myectomy, run by Tongji Hospital at 1 site in China.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 May 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative information 1 (time frame: During surgery, when use isoproterenol to provocate). The study lists 10 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 2 May 2024.