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Device

ADO II AS (PDA closure) for Patent Ductus Arteriosus (ADO II AS Trial)

N/A
Waitlist Available
Led By Evan Zahn, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the 6-month follow-up
Awards & highlights

ADO II AS Trial Summary

This trial is testing a device to help people with a patent ductus arteriosus, a heart condition. The device is placed using a catheter through the femoral artery and monitored with fluoroscopy and echocardiography. Up to 50 people will be enrolled in the trial, with follow-up for 3 years.

Eligible Conditions
  • Patent Ductus Arteriosus

ADO II AS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Secondary outcome measures
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta

ADO II AS Trial Design

1Treatment groups
Experimental Treatment
Group I: PDA closureExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADO II AS (PDA closure)
2017
N/A
~200

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,281 Total Patients Enrolled
Evan Zahn, MDPrincipal InvestigatorCedars-Sinai Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Catheterization and Cardiovascular InterventionsJournal
Amplatzer Piccolo Occluder Clinical Trial for Percutaneous Closure of the Patent Ductus Arteriosus in Patients ≥700 Grams
Sathanandam, Shyam K., Dan Gutfinger, Laura O'Brien, Thomas J. Forbes, Matthew J. Gillespie, Darren P. Berman, Aimee K. Armstrong, et al.. 2020. “Amplatzer Piccolo Occluder Clinical Trial for Percutaneous Closure of the Patent Ductus Arteriosus in Patients ≥700 Grams”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.28973.
clinicaltrials.govStudy
AMPLATZER Duct Occluder II Additional Sizes
2017. "AMPLATZER Duct Occluder II Additional Sizes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03055858.
~26 spots leftby Apr 2025
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