Congenital Heart Disease
Conditions
Keywords
Ductus, Patent ductus Arterious, Nit-Occlud® PDA-R, Interventional closure of PDA, Percutaneous closure
Brief summary
The purpose of this study is to evaluate the safety and the effectiveness of the device Nit-Occlud® PDA-R in the percutaneous closure of patent ductus.
Detailed description
During the years 2003 to 2008, the Cardiological Medical Center Kardiozentrum evaluated 1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with patent arterial duct. The PDA is an abnormal communication between the aorta and pulmonary artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency. The incidence of ducts as an isolated heart disease is between 3.6 and 7% of all congenital heart diseases at sea level, and 10 - 14% at high altitude; rising up to 20% in cities at more than 2.500 m about sea level. The ducts at high altitude are generally wider and larger than at sea level. One treatment alternative is a percutaneous transluminal implantation of a permanent implant which closes the defect. The device under investigation Nit-Occlud® PDA-R is developed for closure of the PDA with a minimal diameter of 2-8 mm. The device performs the function of generating the defect occlusion by the body itself. The implant stimulates the body to generate an epithelium over the implant so that the PDA closes.
Interventions
DEVICENit-Occlud® PDA-R
Transcatheter implantation of a PDA Device (Nitinol) The catheterism was done under sedation, using a protocol established by inserting a catheter through a femoral artery and/or vein directed to the heart and great vessels. Invasive measurements are obtained in the descending aorta and pulmonary artery. Once in ductal position, we inject iodinated contrast medium that allows us to observe via X-ray the ductal morphology; obtaining accurate measurements to choose the appropriate device. The device is then inserted via the catheter, closing the ductus. The catheterism provides measures of aortic and pulmonary pressure, before, during and after the closure.
Sponsors
pfm S.R.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical and echocardiographic compatibility with PDA without associated heart disease requiring surgical solution * Minimum diameter of the PDA 2 to 8 mm * Systolic pulmonary pressure measured during cardiac catheterization, not on pass 2/3 of the values of the systolic systemic pressure * Weight higher than 10 kg, regardless of age * Patients who were diagnosed and recruited during the period 2009 - 2010 * Patients with trisomy 21 also fulfill the previous criteria, the number of patients with T21 will not exceed 10% of the entire group of patients. * letter of consent signed by parents or legal guardian Relative
Exclusion criteria
* Infections that occur during acute bacteremia, viremia, which can be treated * Febrile syndrome * Tooth decay * Once the acute solved considering the patient's inclusion into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment) | up to one year after percutaneous closure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | one year after percutaneous closure | 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. |
Countries
Bolivia
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Effectiveness of the Device: Nit-Occlud® PDA-R |
|---|---|
| Age, Categorical <=18 years | 28 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age Continuous | 5 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment Bolivia | 29 units=participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
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.
Time frame: up to one year after percutaneous closure
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Closure in the Control Period | 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) | 10 Participants |
| Closure in the Control Period | 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) | 6 Participants |
| Closure in the Control Period | 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) | 1 Participants |
| Closure in the Control Period | 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) | 0 Participants |
| Closure in the Control Period | 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) | 0 Participants |
| Closure in the Control Period | 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) | 0 Participants |
| Closure in the Control Period | 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) | 19 Participants |
| Closure in the Control Period | 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) | 23 Participants |
| Closure in the Control Period | 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) | 28 Participants |
| Closure in the Control Period | 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) | 29 Participants |
| Closure in the Control Period | 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) | 29 Participants |
| Closure in the Control Period | 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) | 29 Participants |
Comparison: It is not a analysis of two groups. Only one group of patients was analyzed.p-value: <0.01percentage
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.
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.
Time frame: one year after percutaneous closure
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Closure in the Control Period | 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) | 29 participants |
| Closure in the Control Period | 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) | 29 participants |
Comparison: It is a one arm clinical study. No comparison between groups was made.p-value: <0.01percentage