The U.S. PDA Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04205877|
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
|Condition or disease||Intervention/treatment|
|Ductus Arteriosus, Patent||Device: Transcatheter PDA Closure|
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||The United States Patent Ductus Arteriosus Registry|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2030|
|Estimated Study Completion Date :||December 1, 2031|
All participants will have the same data collected at the same time points.
Device: Transcatheter PDA Closure
Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
- Vascular Access Complications (Safety) [ Time Frame: 6 months ]Access vessel complications include femoral arterial or femoral/jugular venous complications noted during the procedure, immediately after the procedure or delayed (>24 hours). They range from bleeding from access sites, arterial or venous thrombosis with or without the need for treatment to loss of limb secondary to arterial occlusion.
- Valvular Injury (Safety) [ Time Frame: 6 months ]Valvular injury includes damage to the tricuspid valve or other cardiac valve resulting in immediate post-procedural valvular dysfunction.
- Device Embolization (Safety) [ Time Frame: 6 months ]Device embolization includes malposition of the device either during or after the procedure or delayed (>24 hours). The outcome of device embolization ranges from observation, transcatheter retrieval at time of procedure or at a separate time, surgical retrieval, other end organ damage, to mortality.
- Pulmonary or Aortic Vessel Stenosis (Safety) [ Time Frame: 6 months ]Adjacent vessel stenosis includes a narrowing of the aorta or the left pulmonary artery directly as a consequence of device implantation for PDA closure. Vessel stenosis could happen either during or after the procedure or delayed (>24 hours). The outcome of vessel stenosis ranges from no intervention needed to repeated transcatheter and surgical therapies.
- Rate of Effective PDA Closure (Effectiveness) [ Time Frame: 6 months ]The effectiveness endpoint is the rate of effective closure of the PDA using a transcatheter device within six months post procedure. If more than one attempt is required, or multiple devices are required during the same procedure, it is still considered effective if there is Grade 0 or Grade 1 shunt, as defined below, at follow-up by transthoracic echocardiography or if a second procedure is not required following the initial attempt. If there is device embolization, adjacent vessel stenosis that required retrieval of the device and replacement during the same procedure with less than Grade 1 shunt during follow-up, it is still considered effective. Conversely, if an AE is noted after the procedure that requires a second procedure for treatment that results in greater than Grade 1 shunt, then the procedure is considered not effective, even if the initial attempt was effective. See protocol for PDA shunt definitions.
- Significant obstruction of the left pulmonary artery [ Time Frame: 6 months ]
Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery
≥35 mmHg by echocardiogram if lung perfusion scan is not available or as determined by the interventional cardiologist based on angiographic appearance.
- Significant obstruction of the aorta [ Time Frame: 6 months ]Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205877
|Contact: Shyam K Sathanandam, MDemail@example.com|
|Contact: Jorden Cunningham, BSNfirstname.lastname@example.org|
|Principal Investigator:||Shyam Sathanandam, MD||National Principal Investigator|