Hypertrophic Obstructive CardiomyopathyNCT04777188
Speckle Tracking Echocardiography Analysis of Left Ventricular Myocardium After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy
A study testing Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy in people with Hypertrophic Obstructive Cardiomyopathy, run by Xijing Hospital at 1 site in China.
Trial summary
Objective to investigate the left ventricular (LV) systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy (HOCM). 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2016to 9 Jul 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 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
- Patients with a peak LVOT gradient≥50 mm Hg
Who cannot join
- Those with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
- Those with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
- Those with end-stage heart failure；and those the echocardialology image quality is not clear enough for strain 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, 710000
About this study
Official title: Left Ventricular Systolic Function After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy: a Study Focused on Speckle Tracking Echocardiography
Objective to investigate the left ventricular (LV) systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy (HOCM).
Percutaneous intramyocardial septal radiofrequency ablation (named Liwen Procedure) is a safe and effective treatment approach for HOCM and results in sustained improvement in exercise capacity and persistent in reducing left ventricle outflow tract (LVOT) gradient. However, the systolic function of the myocardial after Liwen procedure in HOCM patients is not well exploration and research. Strain evaluation using speckle tracking echocardiography is an excellent tool for assessing regional and global LV functions.
In this study, the investigators aimed to characterize regional and global strain using speckle tracking echocardiography to assess LV radial, circumferential and longitudinal systolic myocardial function in patients with HOCM before and after Liwen procedure.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy
- Keywords
- Cardiomyopathy, hypertrophic, Speckle tracking echocardiography
- 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 Ablation for hypertrophic obstructive cardiomyopathyProcedure 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 | Experimental | Left ventricular systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy. Receives: Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
The left ventricular(LV) systolic function was analyzed by Tomtec Workstation with related software. LV was automatically divided into 16 segments using standard segmentation. The following LV parameters were automatically calculated by the software. The 3D strain indexes derived included ,LV peak systolic global longitudinal strain (GLS,percent), LV peak systolic global radial strain (GRS,percent), LV peak systolic global circumferential strain (GCS,percent)
Measured: 1 year
Secondary outcomes (2)
left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
The results were obtained by continuous Doppler echocardiography (mmHg)
Measured: 1 year
Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
The results were obtained by echocardiography , the unit of mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start22 Oct 2016
- Primary completion1 Jul 2019
- Study completion9 Jul 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
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
- NCT04777188
- Sponsor's protocol ID
- 20162042-1
- Status last verified
- Mar 2021
- First submitted
- 3 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Zhang J, Shi Y, Sievert H, Taub CC, Bertog S, Ta S, Changhui L, Senser E, Wang J, Hu R, Huang J, Ruan F, Han Y, Li X, Wang B, Zhao X, Liu J, Hsi DH, Liu L. Myocardial mechanics of percutaneous intramyocardial septal radiofrequency ablation. Heart. 2023 Jan 27;109(4):289-296. doi: 10.1136/heartjnl-2022-321597.
PubMed 36270787
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Systolic Function After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy: a Study Focused on Speckle Tracking Echocardiography
- ClinicalTrials.gov ID
- NCT04777188
- Acronym / sponsor ID
- 20162042-1
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Keywords
- Cardiomyopathy, hypertrophic, Speckle tracking echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 22 Oct 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 2 Mar 2021 (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.
Objective to investigate the left ventricular (LV) systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy (HOCM).
Percutaneous intramyocardial septal radiofrequency ablation (named Liwen Procedure) is a safe and effective treatment approach for HOCM and results in sustained improvement in exercise capacity and persistent in reducing left ventricle outflow tract (LVOT) gradient. However, the systolic function of the myocardial after Liwen procedure in HOCM patients is not well exploration and research. Strain evaluation using speckle tracking echocardiography is an excellent tool for assessing regional and global LV functions.
In this study, the investigators aimed to characterize regional and global strain using speckle tracking echocardiography to assess LV radial, circumferential and longitudinal systolic myocardial function in patients with HOCM before and after Liwen procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy | Experimental | Procedure: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathyLeft ventricular systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 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
- Patients with a peak LVOT gradient≥50 mm Hg
Key exclusion criteria (3 listed)
- Those with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
- Those with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
- Those with end-stage heart failure；and those the echocardialology image quality is not clear enough for strain 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 Ablation for hypertrophic obstructive cardiomyopathyUnder 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 |
Primary outcome
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Time frame: 1 year
The left ventricular(LV) systolic function was analyzed by Tomtec Workstation with related software. LV was automatically divided into 16 segments using standard segmentation. The following LV parameters were automatically calculated by the software. The 3D strain indexes derived included ,LV peak systolic global longitudinal strain (GLS,percent), LV peak systolic global radial strain (GRS,percent), LV peak systolic global circumferential strain (GCS,percent)
2 secondary outcomes
left ventricular outflow tract gradient before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Time frame: 1 year
Interventricular septal thickness before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation
Time frame: 1 year
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 8 Mar 2021.
- Derived from this study: PubMed 36270787Li J, Zhang J, Shi Y, Sievert H, Taub CC, Bertog S, Ta S, Changhui L, Senser E, Wang J, Hu R, Huang J, Ruan F, Han Y, Li X, Wang B, Zhao X, Liu J, Hsi DH, Liu L. Myocardial mechanics of percutaneous intramyocardial septal radiofrequency ablation. Heart. 2023 Jan 27;109(4):289-296. doi: 10.1136/heartjnl-2022-321597.
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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?
A study testing Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy in people with 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 2 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: finished, as of the sponsor's last update on 8 Mar 2021. 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?
Left ventricular systolic function before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation (time frame: 1 year). 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 NCT04777188, 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 8 Mar 2021.