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

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Septal Defect

Detailed Description

Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.

• Study Type: Observational
• Enrollment (Estimated): 139

Contacts and Locations

• Study Contact: Name: KaDirr Shemsi; Phone Number: +86-176-2130-9203; Email: kadirr@lifetechmed.com
• Study Contact Backup: Name: Jiaxuan Fu; Phone Number: 86+13973207184; Email: fujiaxuan@lifetechmed.com

Study Locations

• Poland
  • Myszków, Poland
    • Not yet recruiting
    • G.V.M.Carint Hospital
  • Oświęcim, Poland
    • Not yet recruiting
    • Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim
  • Sanok, Poland
    • Not yet recruiting
    • Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok
  • Tychy, Poland
    • Recruiting
    • Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Poland Group
    • Contact: Przemyslaw Weglarz; Email: pweglarz@gmail.com
    • Contact: Ewa Konarska Kuszewska; Email: ewakonku@gmail.com
  • Ustroń, Poland
    • Not yet recruiting
    • Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in Ustroń, AHoP Group
  • Zakopane, Poland
    • Not yet recruiting
    • Dr. Tytus Chałubiński County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful closure of the defects	With no, trivial or small residual shunt confirmed by Doppler echocardiography	at procedure, discharge（up to 2 days）and 12 months post-implantation
Incidence of new onset arrhythmia requiring medical treatment	Include medication, intervention or surgical treatment	From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Adverse Events (AEs)	Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study medical device and whether anticipated or unanticipated.	From attempted procedure to 2 years post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)	Adverse event that led to any of the following: death,; serious deterioration in the health of the subject, users, or other persons as defined by one or more of the following:a life-threatening illness or injury, ora permanent impairment of a body structure or a body function including chronic diseases, orin-patient or prolonged hospitalization, ormedical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function,; foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment	From attempted procedure to 2 years post-implantation
Incidence of death	Death	From attempted procedure to 2 years post-implantation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Septal Defect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Heart Septal Defects, Atrial
• Other Study ID Numbers: LT-TS-27-2025-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No