Cera™ ASD Occluder Post-Market Clinical Follow-Up Study

NCT06849635 | Recruiting

• 1 other identifier: LT-TS-27-2025-01
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this post-market study is to:

• collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder
• identify previously unknown side-effects

Conditions

Atrial Septal Defect

Keywords

Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• Procedural success

  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.

  6 months post-implantation

Secondary Outcomes (5)

• Successful closure of the defects

  at procedure, discharge（up to 2 days）and 12 months post-implantation

• Incidence of new onset arrhythmia requiring medical treatment

  From attempted procedure to 2 years post-implantation

• Incidence of device or procedure related Adverse Events (AEs)

  From attempted procedure to 2 years post-implantation

• Incidence of device or procedure related Serious Adverse Events (SAEs)

  From attempted procedure to 2 years post-implantation

• Incidence of death

  From attempted procedure to 2 years post-implantation

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD), who needs endovascular aortic repair.

You may qualify if:

• Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
• Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
• Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.

You may not qualify if:

• Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
• Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
• Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
• Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
• Patients did not conduct any follow up visit after hospital discharge.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (6)

G.V.M.Carint Hospital

Myszków, Poland

NOT YET RECRUITING

Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim

Oświęcim, Poland

NOT YET RECRUITING

Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok

Sanok, Poland

NOT YET RECRUITING

Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group

Tychy, Poland

RECRUITING

Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group

Ustroń, Poland

NOT YET RECRUITING

Dr. Tytus Chałubiński County Hospital

Zakopane, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

KaDirr Shemsi

CONTACT

+86-176-2130-9203; kadirr@lifetechmed.com

Jiaxuan Fu

CONTACT

86+13973207184; fujiaxuan@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 27, 2025
• Study Start: January 3, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

PL (6)