---
title: Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
nct_id: NCT05887700
overall_status: RECRUITING
sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
study_type: OBSERVATIONAL
primary_condition: Atrial Septal Defect
countries: Brazil, Greece, Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05887700.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05887700"
ct_last_update_post_date: 2025-01-08
last_seen_at: "2026-05-12T07:19:39.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

**Official Title:** A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System

**NCT ID:** [NCT05887700](https://clinicaltrials.gov/study/NCT05887700)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 145
- **Lead Sponsor:** Lifetech Scientific (Shenzhen) Co., Ltd.
- **Conditions:** Atrial Septal Defect
- **Start Date:** 2024-07-09
- **Completion Date:** 2027-12
- **CT.gov Last Update:** 2025-01-08

## Brief Summary

The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.

## Detailed Description

The study intends to collect data from patients who have implanted with the device between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions.
2. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion Criteria:

Patients did not conduct any follow up visit after hospital discharge.
```

## Arms

- **ASD subjects** — Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.

## Interventions

- **CeraFlex™ Atrial Septal Defect (ASD) Closure System** (DEVICE) — The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects.

## Primary Outcomes

- **Procedural success** _(time frame: 6 months post-implantation)_ — Procedural success is defined as a composite of:

1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation.
2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.

## Secondary Outcomes

- **Incidence of moderate or large residual shunt** _(time frame: At procedure, 6 months and 12 months post-implantation)_
- **Incidence of device or procedure related Adverse Events (AEs)** _(time frame: From attempted procedure to 24 months post-implantation)_
- **Incidence of device or procedure related Serious Adverse Events (SAEs)** _(time frame: From attempted procedure to 24 months post-implantation)_
- **Incidence of Device Deficiencies (DD)** _(time frame: From attempted procedure to 24 months post-implantation)_
- **Incidence of death** _(time frame: From attempted procedure to 24 months post-implantation)_

## Locations (7)

- Hospital Pequeno Príncipe, Curitiba, Brazil — _NOT_YET_RECRUITING_
- Universidade Federal do Ceará, Fortaleza, Brazil — _NOT_YET_RECRUITING_
- Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil — _NOT_YET_RECRUITING_
- HCOR - Associação Beneficente Síria, São Paulo, Brazil — _NOT_YET_RECRUITING_
- Hospital Beneficência Portuguesa, São Paulo, Brazil — _NOT_YET_RECRUITING_
- Onassis Cardiac Surgery Center, Kallithea, Greece — _RECRUITING_
- IRCCS Policlinico San Donato, Milan, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital pequeno príncipe|curitiba||brazil` — added _(2026-05-12)_
- `locations.universidade federal do ceará|fortaleza||brazil` — added _(2026-05-12)_
- `locations.santa casa de misericórdia de porto alegre|porto alegre||brazil` — added _(2026-05-12)_
- `locations.hcor - associação beneficente síria|são paulo||brazil` — added _(2026-05-12)_
- `locations.hospital beneficência portuguesa|são paulo||brazil` — added _(2026-05-12)_
- `locations.onassis cardiac surgery center|kallithea||greece` — added _(2026-05-12)_
- `locations.irccs policlinico san donato|milan||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05887700.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05887700*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*