Hypertrophic Obstructive CardiomyopathyNCT02888132
Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy
A study testing Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum and Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum in people with Hypertrophic Obstructive Cardiomyopathy, run by Xijing Hospital at 1 site in China.
Trial summary
Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy
- What is being tested?
- Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum and Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation
- Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum
- Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication
- Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test
- Subject over 18 years old
Who cannot join
- Subject has non-obstructive hypertrophic cardiomyopathy
- Subject has combined cerebral vascular diseases
- Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting.
- Subject has end-stage heart failure
- Subject has intraventricular septal thickness (IVST) ≥ 30mm
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Liwen Liu, MD, 86-13571975528, liuliwencrt@hotmail.com
About this study
Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is introduced to patients with refractory symptoms or drug resistance. Considering the sternotomy and relatively high patients' tolerance required in myectomy, the potentially risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic septum, and the potential risk of conduction block after these two treatments, the development of new minimally invasive approach is warranted.
Previous researches have illustrated the effectiveness and feasibility of transcatheter radio frequency ablation for HOCM patients. By far, there has been no report on transthoracic laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid tumors treatment, including liver tumors and fibroid. Also our center has conducted several animal experiments to verify the feasibility of radio frequency/laser in septal myocardium ablation.
The purpose of this study is to lead echocardiography-guided transthoracic radio frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans for HOCM patients, and verify the safety and validity of intervention treatment in long term.
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Being tested
- Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum, Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septumProcedure or surgery
Echocardiography-guided transthoracic laser ablation for HOCM ventricular septumProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic Obstructive Cardiomyopathy | Experimental | Not described Receives: Procedure: Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum; Procedure: Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 24 months
Quantification of obstructive severity
Investigators use pressure gradient of left ventricular outflow tract (LVOT) to quantify obstructive severity. If the pressure gradient increases, the symptom gets deteriorated; if the pressure gradient decreases, the symptom gets relieved.
Measured: 24 months
Secondary outcomes (2)
Quantification of cardiac function
Investigators use ejection function (EF) to quantify the systolic function. If EF is higher after the operation, the systolic function gets improved; if EF lower after the operation, the systolic function gets deteriorate. Investigators use diastolic degree to evaluate the diastolic function. If diastolic degree is lower after the operation, the diastolic function gets improved; If diastolic degree is higher after the operation, the diastolic function gets deteriorated.
Measured: 24 months
Quantification of conduction block
If there is no conduction block observed, the therapy is successful; if there is conduction block, it could be considered as one potential complication.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 10 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
- NCT02888132
- Sponsor's protocol ID
- KY20162042-1
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
Publications
Ta S, Li J, Hsi DH, Hu R, Lei C, Shan B, Li W, Wang J, Wang B, Kang N, Li X, Liu J, Qi C, Huang J, Han Y, Ruan F, Zhang J, Liu L. Percutaneous intramyocardial septal radiofrequency ablation after 5-year follow-up. Heart. 2024 May 10;110(11):792-799. doi: 10.1136/heartjnl-2023-323606.
PubMed 38388470Wang XY, Wang B, Zhu XL, Ma ZL, Liu Y, Lei CH, Yang QL, Hu D, Zhao XL, Liu ZR, Liu LW. Clinical and molecular characterization of seven patients with Danon disease. Exp Ther Med. 2021 Apr;21(4):395. doi: 10.3892/etm.2021.9826. Epub 2021 Feb 24.
PubMed 33680117
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02888132
- Acronym / sponsor ID
- KY20162042-1
- Conditions
- Hypertrophic Obstructive Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2018 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Hypertrophic Obstructive Cardiomyopathy (HOCM) patients have significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope. Conservative medications are used to treat the vast majority of patients. Invasive therapy, which includes surgical myectomy, septal ethanol ablation and dual-chamber pacing is introduced to patients with refractory symptoms or drug resistance. Considering the sternotomy and relatively high patients' tolerance required in myectomy, the potentially risky misplacement of ethanol and the anatomic variability of the vascularised hypertrophic septum, and the potential risk of conduction block after these two treatments, the development of new minimally invasive approach is warranted.
Previous researches have illustrated the effectiveness and feasibility of transcatheter radio frequency ablation for HOCM patients. By far, there has been no report on transthoracic laser-induced interstitial thermotherapy (LITT) for human treatment. Since 2004, our department has adopted High Intensity Focused Ultrasound, radio frequency and laser in solid tumors treatment, including liver tumors and fibroid. Also our center has conducted several animal experiments to verify the feasibility of radio frequency/laser in septal myocardium ablation.
The purpose of this study is to lead echocardiography-guided transthoracic radio frequency/laser ablation for HOCM ventricular septum, make minimally invasive treatment plans for HOCM patients, and verify the safety and validity of intervention treatment in long term.
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: Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum, Procedure: Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation
- Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum
- Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication
- Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test
- Subject over 18 years old
Key exclusion criteria (5 listed)
- Subject has non-obstructive hypertrophic cardiomyopathy
- Subject has combined cerebral vascular diseases
- Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting.
- Subject has end-stage heart failure
- Subject has intraventricular septal thickness (IVST) ≥ 30mm
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 |
|---|---|---|
| Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum | Procedure or surgery | Hypertrophic Obstructive Cardiomyopathy |
| Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum | Procedure or surgery | Hypertrophic Obstructive Cardiomyopathy |
Primary outcome
Mortality
Time frame: 24 months
Quantification of obstructive severity
Time frame: 24 months
Investigators use pressure gradient of left ventricular outflow tract (LVOT) to quantify obstructive severity. If the pressure gradient increases, the symptom gets deteriorated; if the pressure gradient decreases, the symptom gets relieved.
2 secondary outcomes
Quantification of cardiac function
Time frame: 24 months
Quantification of conduction block
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Derived from this study: PubMed 38388470Ta S, Li J, Hsi DH, Hu R, Lei C, Shan B, Li W, Wang J, Wang B, Kang N, Li X, Liu J, Qi C, Huang J, Han Y, Ruan F, Zhang J, Liu L. Percutaneous intramyocardial septal radiofrequency ablation after 5-year follow-up. Heart. 2024 May 10;110(11):792-799. doi: 10.1136/heartjnl-2023-323606.
- Derived from this study: PubMed 33680117Wang XY, Wang B, Zhu XL, Ma ZL, Liu Y, Lei CH, Yang QL, Hu D, Zhao XL, Liu ZR, Liu LW. Clinical and molecular characterization of seven patients with Danon disease. Exp Ther Med. 2021 Apr;21(4):395. doi: 10.3892/etm.2021.9826. Epub 2021 Feb 24.
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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.
Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University
Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum and Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum 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 5 inclusion and 5 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 2 Sep 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT02888132, which also lists 2 linked publications.
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 Sep 2016.