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NCT Number: NCT06700174

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

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)

Recruiting

Interested in participating?

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Key information

Conditions

Atrial Septal Defect (ASD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara (Bilkent) City Hospital, Ankara, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sizing success rate

    Time frame: At procedure

    The size of the selected occluder is proper by echocardiography observing

  2. Incidence of major adverse events (MAEs)

    Time frame: From attempted procedure to discharge, up to 14 days

    Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.

Secondary outcomes

  1. Device success rate

    Time frame: At procedure

    Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.

  2. Incidence of procedure and/or device-related complications

    Time frame: From attempted procedure to discharge, up to 14 days

    Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava.

  3. Incidence of Serious Adverse Events

    Time frame: From attempted procedure to discharge, up to 14 days

  4. Incidence of Device Deficiency (DD)

    Time frame: From attempted procedure to discharge, up to 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Fu Jiaxuan

CONTACT

[email protected]

86 13973207184

Shen Yuanyuan

CONTACT

[email protected]

86+18504356312

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Prospective, Single-arm, Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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