Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

Study Overview

• Status: Completed
• Conditions: Patent Ductus Arteriosus
• Intervention / Treatment: Device: Occlutech PDA occluder

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia
    • IJN National Heart Institute
• Vietnam
  • Hochiminh city, Vietnam
    • Pediatric Hospital no 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a demonstrated patent ductus arteriosus
2. Female or male
3. Belonging to any ethnic group
4. Age between > 6 months and 70 years
5. Body weight > 6 kg < 120 kg

Exclusion Criteria:

1. Associated congenital cardiac anomalies,
2. Body weight < 6 Kilograms

General exclusion criteria

• 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
• Nitinol intolerance (nickel or titanium)
• contrast medium intolerance
• patients who have a vascular system which is too small to admit the required sheath
• patients with pulmonary hypertension and pulmonary-vascular resistance of >8 Woods Units or a lung - / systemic resistance (PR/SR) of >0.4.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PDA Occluder; single arm	Device: Occlutech PDA occluder; Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful closure of patent ductus arterious without evidence of any complication assessed by echocardiongram, ECG and X-ray 30 and 90 days after implant.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Successful closure without evidence of residual shunt after 1 year confirmed by echocariodgram. Safety: freedom of major adverse events i.e periherial embolism or endocarditits.	30, 90, 180 and 360 days after implant

Collaborators and Investigators

• Sponsor: Occlutech International AB
• Investigators: Study Chair: Ziyad M Hijazi, Professor, Rush University medical center, Chicago, USA; Principal Investigator: Alwi Mazeni, Dr, IJN Heart Institute, Kuala Lumpur, Malaysia; Principal Investigator: Viet Minh Tri Nguyen, Dr, Pediatric hospital no 2, Hochiminh city, Vietnam

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 18, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimated): November 24, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: Occlutech-PDA1