---
title: "Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study"
nct_id: NCT05957419
overall_status: UNKNOWN
phase: NA
sponsor: Xiang Wei
study_type: INTERVENTIONAL
primary_condition: Hypertrophic Obstructive Cardiomyopathy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05957419.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05957419"
ct_last_update_post_date: 2023-07-24
last_seen_at: "2026-05-12T07:17:20.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

**Official Title:** Minimally Invasive Transapical Septal Myectomy in the Beating Hearts for the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study

**NCT ID:** [NCT05957419](https://clinicaltrials.gov/study/NCT05957419)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1000
- **Lead Sponsor:** Xiang Wei
- **Collaborators:** Guangdong Provincial People's Hospital, Beijing Anzhen Hospital, Fudan University, Second Hospital of Jilin University
- **Conditions:** Hypertrophic Obstructive Cardiomyopathy
- **Start Date:** 2023-07
- **Completion Date:** 2025-10
- **CT.gov Last Update:** 2023-07-24

## Brief Summary

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, multi-center study.

## Detailed Description

Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, the investigators have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, participants is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

## Eligibility

- **Minimum age:** 8 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
2. Patients with heart function of New York Heart Association ≥ class II.
3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
4. 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

Exclusion Criteria:

1. Patients who were pregnant.
2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
4. Patients whose estimated life expectancy \< 12 m.
5. Patient who were non-compliant.
6. Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.
```

## Arms

- **Hypertrophic Obstructive Cardiomyopathy** (EXPERIMENTAL) — Transapical beating-heart septal myectomy for the patient with hypertrophic obstructive cardiomyopathy.

## Interventions

- **Transapical beating-heart septal myectomy** (PROCEDURE) — 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.

## Primary Outcomes

- **All-cause mortality** _(time frame: 3 months)_ — Death from any cause during the observation period.
- **Number of participants with procedural success** _(time frame: 3 months)_ — Resting left ventricle outflow tract gradients \< 30 mmHg, provoked left ventricle outflow tract gradients \< 50 mmHg, and mitral regurgitation (MR) ≤ grade 1+.

## Secondary Outcomes

- **Number of participants with device success** _(time frame: 1 day)_
- **Septal thickness** _(time frame: 7 days and 3 months)_
- **Left ventricle mass** _(time frame: 7 days and 3 months)_
- **Left atria volume** _(time frame: 7 days and 3 months)_
- **Major adverse cardiovascular and cerebral events** _(time frame: 3 months)_
- **New York Heart Association class** _(time frame: 7 days and 3 months)_
- **6-minute walking test** _(time frame: 3 months)_
- **Score of the Kansas City Cardiomyopathy Questionnaire** _(time frame: 7 days and 3 months)_
- **Left ventricular outflow tract gradient** _(time frame: 7 days and 3 months)_
- **Grade of mitral regurgitation** _(time frame: 7 days and 3 months)_
- **Left ventricular outflow tract diameter** _(time frame: 7 days and 3 months)_
- **Number of Participants with technical success** _(time frame: 7 days or before discharge)_
- **Grade of systolic anterior motion** _(time frame: 7 days and 3 months)_

## Locations (1)

- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tongji hospital, tongji medical college, huazhong university of science and technology|wuhan|hubei|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05957419.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05957419*  
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