Obstructive Hypertrophic CardiomyopathyNCT06224621
Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy
A study testing Percutaneous Endocardial Septal Radiofrequency Ablation in people with Obstructive Hypertrophic Cardiomyopathy, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Percutaneous Endocardial Septal Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Jan 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of hypertrophic cardiomyopathy;
- At least 18 years old;
- The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
- Willing to receive PESA treatment;
- LVEF≥55%;
- Signed and dated written informed consent and willing to return for clinical follow-up.
Who cannot join
- Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
- Complete right bundle branch block;
- Acute decompensation heart failure with NYHA IV;
- Previous septal reduction therapy including surgical and interventional procedures;
- Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
- Contraindications of radiofrequency ablation procedure;
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- Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
- Currently enrolled in another investigational device or drug trial;
- Combining any other clinical condition with a life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
Lingmin Wu, 18810488351, wlmxt2008@126.com
About this study
Official title: Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial
This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:
- the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
- the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- Percutaneous Endocardial 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 Endocardial Septal Radiofrequency AblationProcedure or surgery
Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients. Receives: Procedure: Percutaneous Endocardial Septal Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LVOT gradiant/midventricular gradient
Change in Left ventricular outflow tract gradient pre- and post- intervention
Measured: 6 months,9 months and 12 months
Secondary outcomes (13)
Change in 6 minute walking test
Change in 6 minute walking distance pre- and post- intervention
Measured: 6 months,9 months and 12 months
Change in NYHA cardiac function class
A system used to categorize the severity of heart failure based on the functional limitations of individuals.
Measured: 6 months,9 months and 12 months
Change in cTnT
Cardiac biomarker
Measured: 6 months,9 months and 12 months
Change in cTnI
Cardiac biomarker
Measured: 6 months,9 months and 12 months
Change in NT-proBNP
Cardiac biomarker
Measured: 6 months,9 months and 12 months
Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient reported outcome instrument with minimum score = 0 and maximum score = 100 where higher score indicates better health status. There are no units to the score. The instrument utilizes a recall period of 2 weeks over which patients describe the frequency and severity of their symptoms, their physical and social limitations, and how they perceive their heart failure symptoms to affect their quality of life. quality of life
Measured: 6 months,9 months and 12 months
Change in Left ventricular ejection fraction (LVEF)
LVEF measured by echocardiography
Measured: 6 months,9 months and 12 months
Change in Left ventricular end-diastolic diameter (LVEDD)
LVEDD measured by echocardiography
Measured: 6 months,9 months and 12 months
Change in Left atrial diameter (LAD)
LAD measured by echocardiography
Measured: 6 months,9 months and 12 months
Change in Maximal wall thickness (MWT)
MWT measured by echocardiography
Measured: 6 months,9 months and 12 months
Change in Left ventricular mass index (LVMi)
LVMi measured by cardiac magnetic resonance
Measured: 6 months,9 months and 12 months
Change in Late gadolinium enhancement (LGE)
LGE measured by cardiac magnetic resonance
Measured: 6 months,9 months and 12 months
Change in Cardiac index (CI)
CI measured by cardiac magnetic resonance
Measured: 6 months,9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start31 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224621
- Sponsor's protocol ID
- 2023-ZX012
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endocardial Septal Radiofrequency Ablation in the Treatment of Obstructive Hypertrophic Cardiomyopathy: a Prospective, Multicenter, Single-arm Objective Performance Criteria Trial
- ClinicalTrials.gov ID
- NCT06224621
- Acronym / sponsor ID
- 2023-ZX012
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 25 Jan 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.
This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:
- the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
- the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Percutaneous Endocardial Septal Radiofrequency AblationPercutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of hypertrophic cardiomyopathy;
- At least 18 years old;
- The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
- Willing to receive PESA treatment;
- LVEF≥55%;
Key exclusion criteria (9 listed)
- Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
- Complete right bundle branch block;
- Acute decompensation heart failure with NYHA IV;
- Previous septal reduction therapy including surgical and interventional procedures;
- Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
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 Endocardial Septal Radiofrequency AblationPercutaneous Endocardial Septal Radiofrequency Ablation (PESA) is used to ablatethe hypertrophied septum of obstructive hypertrophic cardiomyopathy (oHCM) patients. | Procedure or surgery | Study group |
Primary outcome
Change in LVOT gradiant/midventricular gradient
Time frame: 6 months,9 months and 12 months
Change in Left ventricular outflow tract gradient pre- and post- intervention
13 secondary outcomes
Change in 6 minute walking test
Time frame: 6 months,9 months and 12 months
Change in NYHA cardiac function class
Time frame: 6 months,9 months and 12 months
Change in cTnT
Time frame: 6 months,9 months and 12 months
Change in cTnI
Time frame: 6 months,9 months and 12 months
Change in NT-proBNP
Time frame: 6 months,9 months and 12 months
Change in Participant-reported Health-related Quality of Life as Assessed by the KCCQ Score
Time frame: 6 months,9 months and 12 months
Change in Left ventricular ejection fraction (LVEF)
Time frame: 6 months,9 months and 12 months
Change in Left ventricular end-diastolic diameter (LVEDD)
Time frame: 6 months,9 months and 12 months
Change in Left atrial diameter (LAD)
Time frame: 6 months,9 months and 12 months
Change in Maximal wall thickness (MWT)
Time frame: 6 months,9 months and 12 months
Change in Left ventricular mass index (LVMi)
Time frame: 6 months,9 months and 12 months
Change in Late gadolinium enhancement (LGE)
Time frame: 6 months,9 months and 12 months
Change in Cardiac index (CI)
Time frame: 6 months,9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Endocardial Septal Radiofrequency Ablation in people with Obstructive Hypertrophic Cardiomyopathy, run by China National Center for Cardiovascular Diseases 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 6 inclusion and 9 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 20 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingmin Wu (18810488351, wlmxt2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LVOT gradiant/midventricular gradient (time frame: 6 months,9 months and 12 months). 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 20 May 2024.