Brief Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Brief Title
AMPLATZER Duct Occluder II Clinical Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Patent Ductus Arteriosus
Eligibility Criteria
Inclusion Criteria:
* Subject must have diagnosis of a PDA
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
Exclusion Criteria:
* Subject must not be \< 6 kilograms for the procedure
* Subject must not be \< 6 months of age
* Subject must not be ≥ 18 years of age
* Subject must not have a descending aorta \< 10mm in diameter
* Subject must not have a right to left shunt through the patent ductus arteriosus
* Subject must not have PVR above 8 Woods units or a Rp/Rs \>0.4
* Subject must not have intracardiac thrombus
* Subject must not have additional cardiac anomalies requiring surgical or interventional correction
* Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
* Subject must not have active infection requiring treatment at the time of implant
* Subject must not have contraindication to anticoagulation treatment
* Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\*
* Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
* If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
* Subject must have diagnosis of a PDA
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
Exclusion Criteria:
* Subject must not be \< 6 kilograms for the procedure
* Subject must not be \< 6 months of age
* Subject must not be ≥ 18 years of age
* Subject must not have a descending aorta \< 10mm in diameter
* Subject must not have a right to left shunt through the patent ductus arteriosus
* Subject must not have PVR above 8 Woods units or a Rp/Rs \>0.4
* Subject must not have intracardiac thrombus
* Subject must not have additional cardiac anomalies requiring surgical or interventional correction
* Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
* Subject must not have active infection requiring treatment at the time of implant
* Subject must not have contraindication to anticoagulation treatment
* Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\*
* Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
* If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
Inclusion Criteria
Inclusion Criteria:
* Subject must have diagnosis of a PDA
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
* Subject must have diagnosis of a PDA
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
Gender
All
Gender Based
false
Keywords
patent ductus arteriosus
PDA
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
18 Years
Minimum Age
6 Months
NCT Id
NCT00713700
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
CL00233
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
Primary Outcomes
Outcome Description
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure
SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
Outcome Measure
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
Outcome Time Frame
180 days
Outcome Description
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
Outcome Measure
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
Outcome Time Frame
180 days
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
18
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Pass
Investigator Email
rpass@montefiore.org
Investigator Phone
Categories Mesh Debug
Child Development & Autism --- HEART DEFECTS, CONGENITAL
Child Development & Autism --- CARDIOVASCULAR ABNORMALITIES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood & Bone Marrow Cancers --- CONGENITAL ABNORMALITIES
MeSH Terms
DUCTUS ARTERIOSUS, PATENT
HEART DEFECTS, CONGENITAL
CARDIOVASCULAR ABNORMALITIES
CARDIOVASCULAR DISEASES
HEART DISEASES
CONGENITAL ABNORMALITIES
CONGENITAL, HEREDITARY, AND NEONATAL DISEASES AND ABNORMALITIES