Hypertrophic Obstructive CardiomyopathyNCT06003478
The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Obstructive Cardiomyopathy, run by Xijing Hospital at 1 site in China.
Trial summary
Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation. The goal of this observational study is to explore the incidence of postoperative complications of the Liwen procedure in hypertrophic cardiomyopathy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 30 May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent Liwen Procedure in Xijing Hospital from 2016 October to 2023 July.
Who may be able to join
- Subject with symptoms that limit daily activities (New York Heart Association functional class >II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
- Subject with a peak LVOT gradient≥50 mm Hg
- Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.
Who cannot join
- Subject with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
- Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
- Subject has end-stage heart failure
Trial locations and contacts
1 site in 1 country.
China1 site
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: The Safety and Influencing Factors of Ultrasound-guided Percutaneous Intramyocardial Septal Radiofrequency Ablation (Liwen Procedure) in The Treatment of Hypertrophic Cardiomyopathy
Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation.
The goal of this observational study is to explore the incidence of postoperative complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen procedure in Xijing Hospital. The main question it aims to answer are:
- What is the incidence of complications in HCM patients underwent Liwen Procedure during postoperative hospitalization and a short-term follow-up period?
- What is the relevant factors of complications in HCM patients who underwent Liwen Procedure during postoperative hospitalization and short-term follow-up period? Can the complications of surgical patients during postoperative hospitalization be predicted? Participants have been evaluated using a variety of medical examinations before they underwent Liwen Procedure. Variants collected from medical examination and case history were used to analyze the association with each postoperative complication.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
- Keywords
- Cardiomyopathy, hypertrophic, Hypotension, Postoperative Complication
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Hypotension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)Procedure or surgery
Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller;Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts for up to 12 min and the ablation power is gradually increased from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy Patients | Not described Receives: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications During Hospitalization
Complications including symptomatic postoperative hypotension observed during hospitalization after PIMSRA. The symptomatic postoperative hypotension is defined as systolic blood pressure lower than 90 mmHg documented by invasive or noninvasive blood pressure measurement accompanied by symptoms including dizziness, and cephalalgia, without regard to the duration of hypotension.
Measured: From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.
Secondary outcomes (1)
Postoperative Complications During Follow-up Period
Complications including chronic hypotension or orthostatic hypotension observed during the follow-up period. Chronic hypotension is defined as mean systolic/diastolic blood pressure lower than 90/60 mmHg documented by ambulatory blood pressure monitoring of more than 23 hours. Orthostatic hypotension is defined as a frop of standing and mean sitting SBP ≥20 mm Hg or diastolic BP ≥10 mm Hg, with complaining of dizziness or fall.
Measured: From date of dischargement until the date of first diagnosis of chronic hypotension or orthostatic hypotension, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start21 Jul 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Obstructive CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Retrospective
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Liwen, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003478
- Sponsor's protocol ID
- KY20232228-C-1
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shan B, Li J, Shi Z, Han C, Zhang J, Zhao J, Hu R, Liu L, Ta S. Predictive value of estimated plasma volume for postoperative hypotension in percutaneous intramyocardial septal radiofrequency ablation treating for hypertrophic obstructive cardiomyopathy. BMC Cardiovasc Disord. 2024 Mar 22;24(1):177. doi: 10.1186/s12872-024-03844-9.
PubMed 38519968
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Influencing Factors of Ultrasound-guided Percutaneous Intramyocardial Septal Radiofrequency Ablation (Liwen Procedure) in The Treatment of Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06003478
- Acronym / sponsor ID
- KY20232228-C-1
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- Cardiomyopathy, hypertrophic, Hypotension, Postoperative Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 22 Aug 2023 (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.
Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but a small proportion of patients have complications after the operation.
The goal of this observational study is to explore the incidence of postoperative complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen procedure in Xijing Hospital. The main question it aims to answer are:
- What is the incidence of complications in HCM patients underwent Liwen Procedure during postoperative hospitalization and a short-term follow-up period?
- What is the relevant factors of complications in HCM patients who underwent Liwen Procedure during postoperative hospitalization and short-term follow-up period? Can the complications of surgical patients during postoperative hospitalization be predicted? Participants have been evaluated using a variety of medical examinations before they underwent Liwen Procedure. Variants collected from medical examination and case history were used to analyze the association with each postoperative complication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy Patients | – | Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent Liwen Procedure in Xijing Hospital from 2016 October to 2023 July.
Key inclusion criteria (3 listed)
- Subject with symptoms that limit daily activities (New York Heart Association functional class >II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
- Subject with a peak LVOT gradient≥50 mm Hg
- Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.
Key exclusion criteria (3 listed)
- Subject with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
- Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
- Subject has end-stage heart failure
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 |
|---|---|---|
| Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller;Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts for up to 12 min and the ablation power is gradually increased from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS). | Procedure or surgery | Hypertrophic Obstructive Cardiomyopathy Patients |
Primary outcome
Postoperative Complications During Hospitalization
Time frame: From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.
Complications including symptomatic postoperative hypotension observed during hospitalization after PIMSRA. The symptomatic postoperative hypotension is defined as systolic blood pressure lower than 90 mmHg documented by invasive or noninvasive blood pressure measurement accompanied by symptoms including dizziness, and cephalalgia, without regard to the duration of hypotension.
1 secondary outcome
Postoperative Complications During Follow-up Period
Time frame: From date of dischargement until the date of first diagnosis of chronic hypotension or orthostatic hypotension, assessed up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 38519968Shan B, Li J, Shi Z, Han C, Zhang J, Zhao J, Hu R, Liu L, Ta S. Predictive value of estimated plasma volume for postoperative hypotension in percutaneous intramyocardial septal radiofrequency ablation treating for hypertrophic obstructive cardiomyopathy. BMC Cardiovasc Disord. 2024 Mar 22;24(1):177. doi: 10.1186/s12872-024-03844-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertrophic Obstructive Cardiomyopathy, run by Xijing 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 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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?
Results are not available in the source record.
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?
Postoperative Complications During Hospitalization (time frame: From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003478, which also lists 1 linked publication.
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 22 Aug 2023.