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

Primary Purpose

Patent Ductus Arteriosus

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Occlutech PDA occluder

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus

Eligibility Criteria

6 Months - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Associated congenital cardiac anomalies,
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.

Sites / Locations

IJN National Heart Institute
Pediatric Hospital no 2

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PDA Occluder

Arm Description

single arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01479218

First Posted

November 18, 2011

Last Updated

October 15, 2014

Sponsor

Occlutech International AB

1. Study Identification

Unique Protocol Identification Number

NCT01479218

Brief Title

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

Official Title

Phase 1 Study for Safety and Effectiveness of the New Occlutech PDA Occluder, for Non Surgical Closure of Patent Ductus Arteriosus

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Occlutech International AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Ductus Arteriosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PDA Occluder

Arm Type

Other

Arm Description

single arm

Intervention Type

Device

Intervention Name(s)

Occlutech PDA occluder

Intervention Description

Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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.

Time Frame

30, 90, 180 and 360 days after implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a demonstrated patent ductus arteriosus Female or male Belonging to any ethnic group Age between > 6 months and 70 years Body weight > 6 kg < 120 kg Exclusion Criteria: Associated congenital cardiac anomalies, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ziyad M Hijazi, Professor

Organizational Affiliation

Rush University medical center, Chicago, USA

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Alwi Mazeni, Dr

Organizational Affiliation

IJN Heart Institute, Kuala Lumpur, Malaysia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Viet Minh Tri Nguyen, Dr

Organizational Affiliation

Pediatric hospital no 2, Hochiminh city, Vietnam

Official's Role

Principal Investigator

Facility Information:

Facility Name

IJN National Heart Institute

City

Kuala Lumpur

Country

Malaysia

Facility Name

Pediatric Hospital no 2

City

Hochiminh city

Country

Vietnam

12. IPD Sharing Statement

Learn more about this trial

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

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