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The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMPLATZER Duct Occluder II | Device | AMPLATZER Duct Occluder II |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. | 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. | 180 days |
| The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. | 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. | 180 days |
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Inclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Health Center | San Diego | California | 92123 | United States | ||
| University of California San Francisco Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Francisco |
| California |
| 94143-0544 |
| United States |
| The Children's Hospital - Denver | Aurora | Colorado | 80045 | United States |
| Alfred I. DuPont Hospital for Children -Nemours Cardiac Center | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Memorial Regional Hospital (Joe DiMaggio Children's Hospital) | Hollywood | Florida | 33021 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| The Children's Hospital Montefiore | The Bronx | New York | 10467 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| The Children's Hospital at Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4399 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232-9119 | United States |
| University of Texas SW Medical Center | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital | Houston | Texas | 77030-2399 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital and Regional Medical Center | Seattle | Washington | 98105-0371 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device | AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. | 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. | Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up. | Posted | Number | 95% Confidence Interval | percentage of participants | 180 days |
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| |||||||||||||||||||||||||
| Primary | The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. | 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. | Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended. | Posted | Number | 95% Confidence Interval | percentage of participants | 180 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device | AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II | 3 | 192 | 19 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Embolization | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Residual shunt requiring closure | Surgical and medical procedures | Systematic Assessment |
| ||
| Sinus tachycardia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashish Oza | Abbott | 1-818-493-3648 | aoza@sjm.com |
| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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