PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

June 15, 2023 updated by: Occlutech International AB

A Multicenter, International, Prospective,Retrospective, PMCF Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects

This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Indication The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) .Occlutech Occlusions-Pusher (OOP) and Occlutech Delivery Set (ODS) are recommended as delivery systems.

Study purpose This study aims to evaluate the safety and efficacy of The Occlutech PDA Occluder devices in patients with patent ductus arteriosus defects (PDA).

Study design This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech® PDA occlude in subjects with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

A sample size of N = 217 evaluable subjects will allow to estimate a proportion of ≤10% (or ≥90%) with precision of 4% at an alpha level of 5%. I.e., the total width of the two-sided 95%-confidence interval will be ≤8%.

Accounting for an anticipated, maximum drop-out (e.g., patients being not evaluable for the primary endpoints due to missing follow-up) rate of 15%, a total number of 255 subjects needs to be enrolled. Besides, N=217 evaluable patients guarantee two-sided 95%-CIs for continuous variables' means having a width of ~0.27 standard deviations (SD). This precision is sufficient for the descriptive objectives.

255 subjects treated for the non-surgical occlusion of PDA with the Occlutech® PDA Occluder. One should note that the majority (~ 90%) of the subjects will be children of young age (0-10 years).

Study objectives To evaluate the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

To evaluate the efficacy of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

Study Type

Observational

Enrollment (Estimated)

255

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

  • Italy
      • Roma, Italy, 00146
        • Not yet recruiting
        • Ospedale Pediatrico Bambin Gesù
        • Contact:
        • Principal Investigator:
          • Paolo Guccione, Prof. Dr.
  • Pakistan
      • Rawalpindi, Pakistan
        • Recruiting
        • Rawalpindi Institute of Cardiology
        • Contact:
        • Principal Investigator:
          • Abdul Malik Sheikh, Prof.Dr.
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Military Hospital
        • Contact:
        • Principal Investigator:
          • Nahdem Hajlaoui, Dr.
        • Sub-Investigator:
          • Wafa Fehri, Dr.
        • Sub-Investigator:
          • Houaida Mahfoudhi, Dr.
  • Turkey
      • Eskişehir, Turkey, 26040
        • Recruiting
        • Eskişehir Osmangazi University Hospital
        • Contact:
        • Principal Investigator:
          • Birsen Uçar, Prof. Dr.
        • Sub-Investigator:
          • Ahmet Sari, Prof. Dr.
    • Efeler
      • Aydın, Efeler, Turkey
        • Recruiting
        • Aydın Adnan Menderes University Hospital
        • Principal Investigator:
          • Serkan Fazlı Çelik
        • Contact:
    • SUR
      • Diyarbakır, SUR, Turkey
        • Recruiting
        • Dicle University Hospital
        • Principal Investigator:
          • Alper Akın
        • Contact:
        • Sub-Investigator:
          • Mehmet Türe
    • Sarıçam
      • Adana, Sarıçam, Turkey
        • Recruiting
        • Çukurova University Hospital
        • Contact:
        • Principal Investigator:
          • Fadli Demir
        • Sub-Investigator:
          • Nazan Özbarlas
  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Not yet recruiting
        • Royal Brompton & Harefield Hospitals
        • Contact:
        • Principal Investigator:
          • Alain Fraisse, Prof. Dr.

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

Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA

Description

Inclusion Criteria:

  • A patient of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Exclusion Criteria:

  • Contraindications as laid down in the IFU:
  • Silent ductus or serious pulmonary hypertension:
  • Pulmonary Vascular Resistance (PVR) > 8 Wood Units
  • Presence of a known coagulation disorder
  • Thrombus at the position allocated for the implantation
  • A vein thrombosis in the blood vessels chosen for the introducing system
  • An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.
  • Nitinol intolerance (nickel or titanium)
  • Contrast medium intolerance
  • Patients who have a vascular system (which is used to access the defect) that is too small to admit the required sheath

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
Safety primary endpoint
Time Frame: 1 year
The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring surgery up to 1-year post-implantation.
1 year
Efficacy primary endpoint
Time Frame: 2 years
The primary efficacy endpoint is defined as successful implantation of the Occlutech® PDA Occluder with a complete closure of the PDA (defined as >90% PDA closure represented by no or small residual flow) as assessed by echocardiography post-implantation) within 2-year post- implantation follow-up.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety secondary endpoint
Time Frame: 3 years
Secondary safety endpoints will assess all minor complications such as transient hemolysis, vascular complications not requiring surgery, or all minor complications which are deemed relevant at the discretion of each investigator. Additionally, an assessment of all Serious Adverse Events (SAE) will be included in the analyses.
3 years
Efficacy secondary endpoint
Time Frame: 3 years
Secondary efficacy assessments refer to the variation in the data from baseline to 3 years after the procedure in parameters such as, but not limited to, aortic blood pressure, pulse rate, LVFS, pulmonary artery pressure, and ECG records.
3 years

Collaborators and Investigators

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

Sponsor

Occlutech International AB

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)

December 20, 2021

Primary Completion (Estimated)

October 25, 2026

Study Completion (Estimated)

November 25, 2026

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2020_03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Patent Ductus Arteriosus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe