Hypertrophic Obstructive Cardiomyopathy (HOCM)NCT07003945
Clinical Outcomes of PIMSRA Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study
An observational study of Hypertrophic Obstructive Cardiomyopathy (HOCM), run by Xijing Hospital at 1 site in China.
Trial summary
The Hypertrophic Cardiomyopathy Center of Xijing Hospital pioneered percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) as an innovative treatment for hypertrophic obstructive cardiomyopathy (HOCM) to relieve left ventricular outflow tract obstruction. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- What is being tested?
- Percutaneous Intramyocardial Septal Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2025to 30 Jun 2027
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with HOCM and with drug-refractory symptoms underwent PIMSRA in Xijing Hospital from 2016 to 2025.
Who may be able to join
- All HOCM patients who underwent PIMSRA treatment, including those with left ventricular outflow tract and middle ventricular obstruction;
- Age from 18 to 90 years old.
Who cannot join
- Patients lost to follow-up whose follow-up period did not reach 6 months;
- Incomplete clinical data affected statistical analysis.
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: Clinical Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study
The Hypertrophic Cardiomyopathy Center of Xijing Hospital pioneered percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) as an innovative treatment for hypertrophic obstructive cardiomyopathy (HOCM) to relieve left ventricular outflow tract obstruction. Clinical studies have confirmed PIMSRA's efficacy, safety and reliability, establishing it as a novel alternative for septal reduction therapy. As a novel interventional approach, comprehensive evaluation of its safety and therapeutic effectiveness is warranted.
Therefore, this retrospective study aims to:
Read more
- Investigate postoperative clinical outcomes and their influencing factors in HOCM patients undergoing PIMSRA;
- Analyze morphological and hemodynamic changes including: septal thickness, left ventricular outflow tract gradient, mid-ventricular pressure gradient and left ventricular flow field dynamics;
- Examine correlations between clinical/procedural parameters and clinical symptoms, quality of life and cardiac reverse remodeling indicators.
This study will provide high-quality evidence to support the clinical application of this novel procedure.
- Being tested
- Percutaneous Intramyocardial Septal Radiofrequency Ablation
- Keywords
- Cardiomyopathy, hypertrophic, Treatment outcome, safety, efficacy, Percutaneous intramyocardial septal radiofrequency ablation
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Intramyocardial Septal Radiofrequency AblationProcedure or surgery
With the real-time guidance of TTE, a radiofrequency electrode needle was percutaneously inserted via the transapical intramyocardial approach into the hypertrophied septum for thermal ablation. Intraoperative TTE and 12-lead electrocardiographic monitoring were employed to assess the ablation extent and prevent vascular and cardiac conduction bundle injury. The success of ablation was confirmed by evaluating contrast medium perfusion defects in the ablated areas and comparing them with the preprocedural hypertrophied septum.
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA | Not described Receives: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Major adverse cardiovascular events including but not limited to:
- All-cause death;
- Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation;
- Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization;
- Cardiogenic shock: cardiac disorder that results in a systolic blood pressure <90 mmHg for ≥30 min (or the need for vasopressors, inotropes or mechanical circulatory support to maintain systolic blood pressure ≥90 mmHg) with evidence of hypoperfusion;
- Severe systolic anterior motion: the proximal portion of the anterior mitral leaflet moved excessively close to the septum, resulting in extreme LVOT obstruction and acute haemodynamic collapse;
- Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Procedure-related adverse events
Any instrument or procedure-related complications, including but not limited to death, emergency surgery, pericardial tamponade requiring pericardiocentesis or surgery, bleeding, procedure-related stroke.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Interventricular septal thickness
Maximum septal thickness as measured by echocardiography.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Left ventricular outflow tract gradient
Left ventricular outflow tract gradient as measured by echocardiography.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Secondary outcomes (5)
New York Heart Association Classification
The New York Heart Association Classification involved 4 classes. I-No limitation of physical activity, II-Slight limitation of physical activity, III-Marked limitation of physical activity, IV-Unable to carry on any physical activity without discomfort. A higher grade means worse heart function.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Kansas City Cardiomyopathy Questionnaire score
The Kansas City Cardiomyopathy Questionnaire was a 23-item, self-administered questionnaire that measure the participant's perception of their health status. It quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated from each domain and scaled from 0 to 100, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Late gadolinium enhancement
Late gadolinium enhancement measured by cardiac magnetic resonance.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Mean blood pressure
Mean systolic/diastolic blood pressure measured by ambulatory blood pressure monitoring.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Energy loss
Energy loss measured by vector flow mapping.
Measured: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start29 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive Cardiomyopathy (HOCM)Studies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003945
- Sponsor's protocol ID
- KY20242272-C-1
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Percutaneous Intramyocardial Septal Radiofrequency Ablation Treating for Hypertrophic Obstructive Cardiomyopathy: A Large-Sample Study
- ClinicalTrials.gov ID
- NCT07003945
- Acronym / sponsor ID
- KY20242272-C-1
- Keywords
- Cardiomyopathy, hypertrophic, Treatment outcome, safety, efficacy, Percutaneous intramyocardial septal radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Jun 2025 (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.
The Hypertrophic Cardiomyopathy Center of Xijing Hospital pioneered percutaneous intramyocardial septal radiofrequency ablation (PIMSRA) as an innovative treatment for hypertrophic obstructive cardiomyopathy (HOCM) to relieve left ventricular outflow tract obstruction. Clinical studies have confirmed PIMSRA's efficacy, safety and reliability, establishing it as a novel alternative for septal reduction therapy. As a novel interventional approach, comprehensive evaluation of its safety and therapeutic effectiveness is warranted.
Therefore, this retrospective study aims to:
- Investigate postoperative clinical outcomes and their influencing factors in HOCM patients undergoing PIMSRA;
- Analyze morphological and hemodynamic changes including: septal thickness, left ventricular outflow tract gradient, mid-ventricular pressure gradient and left ventricular flow field dynamics;
- Examine correlations between clinical/procedural parameters and clinical symptoms, quality of life and cardiac reverse remodeling indicators.
This study will provide high-quality evidence to support the clinical application of this novel procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA | – | Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with HOCM and with drug-refractory symptoms underwent PIMSRA in Xijing Hospital from 2016 to 2025.
Key inclusion criteria (2 listed)
- All HOCM patients who underwent PIMSRA treatment, including those with left ventricular outflow tract and middle ventricular obstruction;
- Age from 18 to 90 years old.
Key exclusion criteria (2 listed)
- Patients lost to follow-up whose follow-up period did not reach 6 months;
- Incomplete clinical data affected statistical analysis.
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 AblationWith the real-time guidance of TTE, a radiofrequency electrode needle was percutaneously inserted via the transapical intramyocardial approach into the hypertrophied septum for thermal ablation. Intraoperative TTE and 12-lead electrocardiographic monitoring were employed to assess the ablation extent and prevent vascular and cardiac conduction bundle injury. The success of ablation was confirmed by evaluating contrast medium perfusion defects in the ablated areas and comparing them with the preprocedural hypertrophied septum. | Procedure or surgery | Hypertrophic Obstructive Cardiomyopathy Patients Underwent PIMSRA |
Primary outcome
Major adverse cardiovascular events
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Major adverse cardiovascular events including but not limited to: 1. All-cause death; 2. Arrhythmic events: resuscitated cardiac arrest or ventricular tachycardia/fibrillation, appropriate implantable cardioverter-defibrillator discharge, atrioventricular block, pacemaker implantation and atrial fibrillation; 3. Acute heart failure: acute pulmonary edema, new-onset NYHA class Ⅲ-IV symptoms, and heart failure-related hospitalization; 4. Cardiogenic shock: cardiac disorder that results in a systolic blood pressure <90 mmHg for ≥30 min (or the need for vasopressors, inotropes or mechanical circulatory support to maintain systolic blood pressure ≥90 mmHg) with evidence of hypoperfusion; 5. Severe systolic anterior motion: the proximal portion of the anterior mitral leaflet moved excessively close to the septum, resulting in extreme LVOT obstruction and acute haemodynamic collapse; 6. Cerebrovascular events: all stroke (ischemic or hemorrhagic) and transient ischemic attacks.
Procedure-related adverse events
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Any instrument or procedure-related complications, including but not limited to death, emergency surgery, pericardial tamponade requiring pericardiocentesis or surgery, bleeding, procedure-related stroke.
Interventricular septal thickness
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Maximum septal thickness as measured by echocardiography.
Left ventricular outflow tract gradient
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Left ventricular outflow tract gradient as measured by echocardiography.
5 secondary outcomes
New York Heart Association Classification
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Kansas City Cardiomyopathy Questionnaire score
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Late gadolinium enhancement
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Mean blood pressure
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
Energy loss
Time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.
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 4 Jun 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. 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 (HOCM), 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 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 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?
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?
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?
Major adverse cardiovascular events (time frame: Observations were conducted from the immediate postoperative period through 1-year follow-up, with assessment time points including but not limited to 1 month, 3 months, 6 months, and 1 year.). The study lists 4 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 4 Jun 2025.