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Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
pfm S.R.L.
ClinicalTrials.gov Identifier:
NCT01063712
First received: February 4, 2010
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: February 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Congenital Heart Disease
Intervention: Device: Nit-Occlud® PDA-R

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prospective clinical study between June 2009 and December 2010 in La Paz, Bolivia. 29 out of 59 patients selected with inclusion and exclusion criteria(≥ 10 Kg, Patient Arterial Duct of 2 – 8 mm minimal diameter, "Nit-Occlud® PDA-R" used, systolic pulmonary pressure ≤ 67% of systolic aortic pressure and absence of any other chronic disease).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 patients were excluded. Four and eight patients with Patent Arterial Duct bigger than 8 mm or smaller than 2 mm, eleven patients with pulmonary pressure elevated more than 67% of systolic pressure, nine patients lighter than 10 Kg and three patients with atypical ducts. Some were excluded for more than one reason.

Reporting Groups
  Description
"Nit-Occlud® PDA-R" Implantations Group

Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.

This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated.


Participant Flow:   Overall Study
    "Nit-Occlud® PDA-R" Implantations Group  
STARTED     29  
COMPLETED     29  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Effectiveness of the Device: "Nit-Occlud® PDA-R"

Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.

This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated.


Baseline Measures
    Effectiveness of the Device: "Nit-Occlud® PDA-R"  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     28  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  5  ± 4.8  
Gender  
[units: participants]
 
Female     22  
Male     7  
Region of Enrollment  
[units: units=participants]
 
Bolivia     29  



  Outcome Measures
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1.  Primary:   Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)   [ Time Frame: up to one year after percutaneous closure ]

2.  Secondary:   Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.   [ Time Frame: one year after percutaneous closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The number of participants is small, because the participants were recruited in high altitude cities over 2700m above the sea level. At this altitude bigger defects are more frequent to find than little ones, so is pulmonary hypertension.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alexandra Heath MD Ph.D
Organization: Cardiology Medical Center "Kardiozentrum"
phone: 005912 2785037
e-mail: draheath@gmail.com


Publications of Results:
Other Publications:

Responsible Party: pfm S.R.L.
ClinicalTrials.gov Identifier: NCT01063712     History of Changes
Other Study ID Numbers: PFM-P034, Bioethics Committee
Study First Received: February 4, 2010
Results First Received: February 23, 2011
Last Updated: May 22, 2012
Health Authority: Bolivia: Ethics Committee