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Device

Second Cohort for Ventricular Septal Defects (PIVSD PAS Trial)

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month visit
Awards & highlights

Summary

FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.

Eligible Conditions
  • Ventricular Septal Defects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness Endpoint 1: Technical Success
Effectiveness Endpoint 2: Acute Closure
Effectiveness Endpoint 3: Chronic Closure
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Second CohortExperimental Treatment1 Intervention
This cohort will consist of subjects over the age of 18 years who have previously been successfully implanted with the PIVSD Occluder and * For living subjects, the subject or subject's legally authorized representative has provided consent to participate in this study. * Subject's post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment. Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival.
Group II: First CohortExperimental Treatment1 Intervention
All available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 will be utilized to determine technical success and acute survival. All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMPLATZER™ Post-infarct Muscular VSD Occluder
2018
N/A
~40

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Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
408,502 Total Patients Enrolled
Maren WagnerStudy DirectorSponsor GmbH
3 Previous Clinical Trials
702 Total Patients Enrolled
~5 spots leftby Sep 2025
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