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

Last updated: November 19, 2024
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06700174
LT/TS/571I-2023
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have been confirmed with single secundum atrial septal defect (ASD) byechocardiography;

  2. The anatomy of ASD is suitable for percutaneous closure;

  3. Patients are scheduled to perform ASD closure;

  4. Patients or legally authorized representative(s) who are willing and capable ofproviding informed consent.

Exclusion

Exclusion Criteria:

  1. Any contraindication for ASD closure;

  2. Patients have ostium primum ASD or coronary sinus ASD;

  3. Patients who are pregnant or breastfeeding;

  4. Patient is currently participating in another clinical trial that has not yetcompleted its primary endpoint.

Study Design

Total Participants: 100
Study Start date:
September 24, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Ankara (Bilkent) City Hospital

    Ankara,
    Turkey

    Active - Recruiting

  • Gazi Yasargil Woman and Child Hospital

    Diyarbakir,
    Turkey

    Active - Recruiting

  • Gaziantep University Hospital

    Gaziantep,
    Turkey

    Site Not Available

  • SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Tepecik Training and Research Hospital

    Izmir,
    Turkey

    Active - Recruiting

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