Health TrialsbyHealthPanel

Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy

ConditionHypertrophic Obstructive Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorXiang Wei

About this trial

The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients whose resting or provoked left ventricular outflow tract gradient > 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.

Patients with heart function of New York Heart Association ≥ class II.

Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.

Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.

Disqualifiers

Patients who were pregnant.

Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.

Patients who had severe heart failure with left ventricle ejection fraction < 40%.

Patients whose estimated life expectancy < 12 m.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transapical beating-heart septal myectomy

    Procedure/Surgery

    We have invented a beating-heart myectomy device.Through a minimally invasive intercostal incision, septal myectomy could be accomplished via a transapical access in the beating heart using the device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outlet tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor the muscular resection for sufficient relief of left ventricle outlet tract obstruction and mitral regurgitation, while preventing iatrogenic injuries.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Hypertrophic Obstructive CardiomyopathyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Death from any cause during the observation period.

Time frame
3 months
2

Procedural success

Resting left ventricle outflow tract gradients \< 30 mmHg, provoked left ventricle outflow tract gradients \< 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.

Time frame
3 months

Secondary outcomes

1

Device success

Successful accession, delivery, and retrieval of the resection device, successful resection of the septal myocardium, resting left ventricle outflow tract gradient less than 50 mmHg and mitral regurgitation (MR) ≤ grade 2+ during operation after resection, and free from conversion to midline thoracotomy during operation.

Time frame
1 day
2

Septal thickness

Basal and mid septal thickness as measured by echocardiography.

Time frame
7 days and 3 months
3

Left ventricle mass

Left ventricle mass index (the ratio of left ventricle mass to body weight) as measured by cardiac magnetic resonance.

Time frame
3 months
4

Left ventricle volume

Left ventricle end-diastolic volume as measured by echocardiography.

Time frame
7 days and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiang Wei

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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