Back to resultsSafety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Phase 2
Locations
Bolivia
Study Type
Interventional
Intervention
Nit-Occlud® PDA-R
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Ductus, Patent ductus Arterious, "Nit-Occlud® PDA-R", Interventional closure of PDA, Percutaneous closure
Eligibility Criteria
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
Exclusion Criteria:
- Pregnant women
- Pulmonary hypertension, increased to 2 / 3 of systemic pressure
- Eisenmenger syndrome
- Other associated heart disease, requiring surgical solution
- Immuno-compromised patients
- Pathology oncology
- Hematologic or coagulation disorders
- Allergy to contrast medium
- Atypical or calcified Ductus
- Parents or legal guardians who do not accept the risks of catheterization
- Parents or legal guardians and patients who do not accept to sign the letter of consent or who revoke the consent.
- Patients who participated in another clinical investigation during the last 3 months
Sites / Locations
- Kardiozentrum and Surgical Medical Center Boliviano Belga
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Nit-Occlud PDA-R
Arm Description
Interventional, prospective clinical study, non randomized.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01063712
Brief Title
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
Official Title
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R" for Percutaneous Closure of Patent Arterial Duct Between 2 and 8 mm in Patients Treated Interventionally in Specialized Centers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pfm S.R.L.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Ductus, Patent ductus Arterious, "Nit-Occlud® PDA-R", Interventional closure of PDA, Percutaneous closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nit-Occlud PDA-R
Arm Type
Other
Arm Description
Interventional, prospective clinical study, non randomized.
Intervention Type
Device
Intervention Name(s)
Nit-Occlud® PDA-R
Other Intervention Name(s)
Device - Med - Nit Occlud PDA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Pregnant women
Pulmonary hypertension, increased to 2 / 3 of systemic pressure
Eisenmenger syndrome
Other associated heart disease, requiring surgical solution
Immuno-compromised patients
Pathology oncology
Hematologic or coagulation disorders
Allergy to contrast medium
Atypical or calcified Ductus
Parents or legal guardians who do not accept the risks of catheterization
Parents or legal guardians and patients who do not accept to sign the letter of consent or who revoke the consent.
Patients who participated in another clinical investigation during the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Heath, MD, Ph.D
Organizational Affiliation
Kardiozentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kardiozentrum and Surgical Medical Center Boliviano Belga
City
La Paz
State/Province
Murillo
ZIP/Postal Code
100
Country
Bolivia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19882712
Citation
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.
Results Reference
background
PubMed Identifier
21805617
Citation
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.
Results Reference
background
PubMed Identifier
21774843
Citation
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.
Results Reference
result
Links:
URL
http://www.csi-congress.org/index.php?=812
Description
CSI Frankfurt 08´ - Closure of Very Large PDAs with New Device
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Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
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