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

November 19, 2024 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

A Multicenter, Prospective, Single-arm, Observational 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)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara (Bilkent) City Hospital
        • Contact:
        • Contact:
          • ECE Ibrahim
      • Diyarbakir, Turkey
        • Recruiting
        • Gazi Yasargil Woman and Child Hospital
        • Contact:
        • Contact:
          • ALDUDAK Bedri
      • Gaziantep, Turkey
        • Not yet recruiting
        • Gaziantep University Hospital
        • Contact:
        • Contact:
          • BASPINAR Osman
      • Istanbul, Turkey
        • Not yet recruiting
        • SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital
        • Contact:
        • Contact:
          • DEMIR Halil Ibrahim
      • Izmir, Turkey
        • Recruiting
        • Tepecik Training and Research Hospital
        • Contact:
        • Contact:
          • NARIN Nazmi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.

Description

Inclusion Criteria:

  1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
  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 of providing informed consent.

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 yet completed its primary endpoint.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sizing success rate
Time Frame: At procedure
The size of the selected occluder is proper by echocardiography observing
At procedure
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.
From attempted procedure to discharge, up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device success rate
Time Frame: At procedure
Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.
At procedure
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.
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
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
From attempted procedure to discharge, up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT/TS/571I-2023

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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