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Recruiting NCT06700174

Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

— Observational Atrial Septal Defect (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Septal Defect (ASD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Prospective, Single-arm, Observational Study

Overview

The objective of this PMCF study is to: * confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)

Primary outcome measures

  • Sizing success rate [Time frame: At procedure]
  • Incidence of major adverse events (MAEs) [Time frame: From attempted procedure to discharge, up to 14 days]
Secondary outcome measures (4)
  • Device success rate [Time frame: At procedure]
  • Incidence of procedure and/or device-related complications [Time frame: From attempted procedure to discharge, up to 14 days]
  • Incidence of Serious Adverse Events [Time frame: From attempted procedure to discharge, up to 14 days]
  • Incidence of Device Deficiency (DD) [Time frame: From attempted procedure to discharge, up to 14 days]

Eligibility criteria

Inclusion criteria

  • Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
  • The anatomy of ASD is suitable for percutaneous closure;
  • Patients are scheduled to perform ASD closure;
  • Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

Exclusion criteria

  • Any contraindication for ASD closure;
  • Patients have ostium primum ASD or coronary sinus ASD;
  • Patients who are pregnant or breastfeeding;
  • Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 5 centers
  • Ankara (Bilkent) City Hospital — Ankara
  • Gazi Yasargil Woman and Child Hospital — Diyarbakır
  • Gaziantep University Hospital — Gaziantep
  • SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul
  • Tepecik Training and Research Hospital — Izmir

Identifiers

NCT: NCT06700174 · LT/TS/571I-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗