Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Bioethics Committee | Registry Identifier | 08-06-2009 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-OccludĀ® PDA-R" in the percutaneous closure of patent ductus.
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-OccludĀ® 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nit-Occlud PDA-R | Other | Interventional, prospective clinical study, non randomized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nit-OccludĀ® PDA-R | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to one year after percutaneous closure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Relative Exclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Heath, MD, Ph.D | Kardiozentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kardiozentrum and Surgical Medical Center Boliviano Belga | La Paz | Murillo | 100 | Bolivia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19882712 | Background | Lang N, Schmitz C, Lehner A, Fuchs F, Heath A, Freudenthal F, Wintersperger BJ, Huber AM, Thein E, Netz H, Kozlik-Feldmann R. Preclinical evaluation of a new self-expanding device for closure of muscular ventricular septal defects in a pig model. Catheter Cardiovasc Interv. 2010 Feb 15;75(3):408-15. doi: 10.1002/ccd.22285. | |
| 21805617 |
| Label | URL |
|---|---|
| CSI Frankfurt 08Ā“ - Closure of Very Large PDAs with New Device | View source |
Not provided
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.
Prospective clinical study between June 2009 and December 2010 in La Paz, Bolivia. 29 out of 59 patients selected with inclusion and exclusion criteria(ā„ 10 Kg, Patient Arterial Duct of 2 - 8 mm minimal diameter, "Nit-OccludĀ® PDA-R" used, systolic pulmonary pressure ā¤ 67% of systolic aortic pressure and absence of any other chronic disease).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | "Nit-OccludĀ® 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), havenĀ“t developed pulmonary hypertension and have enough weight to be treated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Effectiveness of the Device: "Nit-OccludĀ® 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), havenĀ“t developed pulmonary hypertension and have enough weight to be treated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Jun 2011 | Number | Participants | up to one year after percutaneous closure |
|
Data on adverse effects was collected over 18 months. Clinical, laboratory and echocardiographic findings were documented in a established protocol.
Controls were made at 24 hours, one week, 1 month, 3 months, six months and 1 year.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Effectiveness of the Device: "Nit-OccludĀ® 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), havenĀ“t developed pulmonary hypertension and have enough weight to be treated. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Heath MD Ph.D | Cardiology Medical Center "Kardiozentrum" | 005912 2785037 | draheath@gmail.com |
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| one year after percutaneous closure |
| Heath A, Lang N, Levi DS, Granja M, Villanueva J, Navarro J, Echazu G, Kozlik-Feldmann R, del Nido P, Freudenthal F. Transcatheter closure of large patent ductus arteriosus at high altitude with a novel nitinol device. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):399-407. doi: 10.1002/ccd.23302. Epub 2011 Dec 12. |
| 21774843 | Result | Freudenthal FP, Heath A, Villanueva J, Mendes J, Vicente X, von Alvensleben I, Echazu G, Navarro J, Lang N, Kozlik-Feldmann R. Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it. Cardiol Young. 2012 Apr;22(2):128-35. doi: 10.1017/S1047951111000990. Epub 2011 Jul 21. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | units=participants |
|
| Closure in the Control Period |
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. |
|
|
|
| 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. | 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. | Posted | Number | participants | one year after percutaneous closure |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |