Trial Outcomes & Findings for Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder (NCT NCT00583596)

NCT ID: NCT00583596

Last Updated: 2023-06-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 436 participants
• Primary outcome timeframe: Long term follow up for data captured at 5, 6 or 7 years post implant
• Results posted on: 2023-06-29

Participant Flow

Subjects were recruited in medical clinics. The first subject enrolled was September 10, 1999. The last follow-up occurred in the Post Market Surveillance Study on August 29, 2008.

Subjects meeting the inclusion/exclusion criteria of the protocol were included in the original clinical trial.

Participant milestones

Measure	Long Term Follow-up for Subjects Implanted With the Device Subjects enrolled in IDE study subject to Post Market Surveillance
Overall Study STARTED	436
Overall Study COMPLETED	152
Overall Study NOT COMPLETED	284

Reasons for withdrawal

Measure	Long Term Follow-up for Subjects Implanted With the Device Subjects enrolled in IDE study subject to Post Market Surveillance
Overall Study Lost to Follow-up	94
Overall Study Excluded due to Hurricane Katrina	30
Overall Study Death	2
Overall Study Withdrawal by Subject	6
Overall Study Data not complete	1
Overall Study Not consented	15
Overall Study Outside f-up window	26

Baseline Characteristics

Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

Baseline characteristics by cohort

Measure	Long Term Follow-up for Subjects Implanted With the Device n=436 Participants Subjects enrolled in IDE study subject to Post Market Surveillance
Age, Continuous	6.14 years STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male Female	298 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants
Region of Enrollment United States	436 participants n=5 Participants

PRIMARY outcome

Timeframe: Long term follow up for data captured at 5, 6 or 7 years post implant

Population: 152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.

Outcome measures

Measure	Long Term Follow-up for Subjects Implanted With the Device n=152 Participants Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
Reporting of Late Adverse Events Relating to the Device.	9 participant

PRIMARY outcome

Timeframe: Long term follow up data captured at 5, 6 or 7 years post implant

Population: Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.

The number of participants with a residual shunt (efficacy)

Outcome measures

Measure	Long Term Follow-up for Subjects Implanted With the Device n=128 Participants Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure	0 participants

Adverse Events

Long Term Follow-up for Subjects Implanted With the Device

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Long Term Follow-up for Subjects Implanted With the Device n=436 participants at risk Subjects enrolled in IDE study subject to Post Market Surveillance
Cardiac disorders Obstruction of Pulmonary Artery with Gradient	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.

Other adverse events

Measure	Long Term Follow-up for Subjects Implanted With the Device n=436 participants at risk Subjects enrolled in IDE study subject to Post Market Surveillance
Cardiac disorders Mitral Valve regurgitation	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Cardiac disorders Left Pulmonary artery stenosis	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Cardiac disorders Aortic Stenosis with Chest Pain	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
General disorders Death	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Cardiac disorders Atrial ectopic beats	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Cardiac disorders Echo finding	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Endocrine disorders Diabetic ketoacidosis	0.23% 1/436 • Number of events 2 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.23% 1/436 • Number of events 1 • Adverse event data was collected during routine follow-up visits or if an event occurred between visits.

Additional Information

Jeffrey Mifek

St. Jude Medical Formally AGA Medical Corporation

Phone: 6517565586

Email: jmifek@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place