Trial Outcomes & Findings for AMPLATZER Duct Occluder II Clinical Study (NCT NCT00713700)

NCT ID: NCT00713700

Last Updated: 2019-02-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 192 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Device AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Overall Study STARTED	192
Overall Study COMPLETED	188
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Device AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

AMPLATZER Duct Occluder II Clinical Study

Baseline characteristics by cohort

Measure	Device n=192 Participants AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Age, Categorical <=18 years	192 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	4.4 years STANDARD_DEVIATION 4.2 • n=93 Participants
Sex: Female, Male Female	120 Participants n=93 Participants
Sex: Female, Male Male	72 Participants n=93 Participants
Region of Enrollment United States	192 participants n=93 Participants

PRIMARY outcome

Timeframe: 180 days

Population: 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.

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.

Outcome measures

Measure	Device n=188 Participants AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.	1.6 percentage of participants Interval 0.33 to 4.59

PRIMARY outcome

Timeframe: 180 days

Population: 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.

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 measures

Measure	Device n=166 Participants AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.	98.19 percentage of participants Interval 94.81 to 99.63

Adverse Events

Device

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Device n=192 participants at risk AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Injury, poisoning and procedural complications Device Embolization	0.52% 1/192 • Number of events 1
Surgical and medical procedures Residual shunt requiring closure	1.0% 2/192 • Number of events 2
Injury, poisoning and procedural complications Sinus tachycardia	0.52% 1/192 • Number of events 1

Other adverse events

Measure	Device n=192 participants at risk AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
General disorders Pain	9.9% 19/192

Additional Information

Ashish Oza

Abbott

Phone: 1-818-493-3648

Email: aoza@sjm.com

Results disclosure agreements

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

Restriction type: OTHER