Clinical Trials Directory

Trials / Unknown

UnknownNCT02888132

Echocardiography-guided Transthoracic Radio Frequency/Laser Ablation for Ventricular Septum of Hypertrophic Obstructive Cardiomyopathy

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
Xijing Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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. 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

Interventions

TypeNameDescription
PROCEDUREEchocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum
PROCEDUREEchocardiography-guided transthoracic laser ablation for HOCM ventricular septum

Timeline

Start date
2016-04-01
Primary completion
2018-05-01
First posted
2016-09-02
Last updated
2016-09-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02888132. Inclusion in this directory is not an endorsement.