Trial Outcomes & Findings for Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" (NCT NCT01063712)
NCT ID: NCT01063712
Last Updated: 2012-05-24
Results Overview
The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.
COMPLETED
PHASE2
29 participants
up to one year after percutaneous closure
2012-05-24
Participant Flow
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).
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.
Participant milestones
| Measure |
"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.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Baseline characteristics by cohort
| Measure |
Effectiveness of the Device: "Nit-Occlud® PDA-R"
n=29 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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28 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age Continuous
|
5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
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Sex: Female, Male
Female
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22 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Region of Enrollment
Bolivia
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29 units=participants
n=5 Participants
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PRIMARY outcome
Timeframe: up to one year after percutaneous closurePopulation: 29 patients were controled in a period of one year and were examinated by echocardiography.The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or "color flow") in the control period is given as number and as percentage of the complete group.
The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.
Outcome measures
| Measure |
Closure in the Control Period
n=29 Participants
The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or "color flow") in the control period is given as number and as percentage of the complete group.
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|---|---|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Complete closure at time 1 (immediate)
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19 Participants
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Complete closure at time 2 (24 hours)
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23 Participants
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Complete closure at time 3 (1 month)
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28 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Complete closure at time 4 (3 months)
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29 Participants
|
|
Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Complete closure at time 5 (6 months)
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29 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
complete closure at time 6 (12 months)
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29 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 1 (immediate)
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10 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 2 (24 hours)
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6 Participants
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 3 (1 month)
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1 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 4 (3 months)
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0 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 5 (6 months)
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0 Participants
|
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Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
partially open at time 6 (12 months)
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0 Participants
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SECONDARY outcome
Timeframe: one year after percutaneous closurePopulation: The patient selection was based in the "consecutive case" and "intention to treat" method. All patients recruited in the determinated time frame (June 2009 to May 2010) who met the initial inclusion criteria were treated in the catheterisation laboratory. There the definite inclusion criteria were applied.
The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.
Outcome measures
| Measure |
Closure in the Control Period
n=29 Participants
The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or "color flow") in the control period is given as number and as percentage of the complete group.
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|---|---|
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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.
Regression at time 1 (immediate)
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29 participants
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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.
Regression at time 5 (6 months)
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29 participants
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Adverse Events
Effectiveness of the Device: "Nit-Occlud® PDA-R"
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexandra Heath MD Ph.D
Cardiology Medical Center "Kardiozentrum"
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place