AMPLATZER Duct Occluder II Additional Sizes

NCT03055858 | Completed Results DMC FDA Device

• 1 other identifier: SJM-CIP-10171
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

Brief Summary

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States. Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.

Conditions

Patent Ductus Arteriosus

Keywords

PDA; SJM-CIP-10171; ADO II AS; IDE; CAP

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant

  Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia

  Through 180 days

• Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant

  The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).

  At the 6-month follow-up

Secondary Outcomes (1)

• The Rate of Significant Obstruction of the Pulmonary Artery or Aorta

  Through 6 month follow-up visit

Study Arms (1)

PDA closure

EXPERIMENTAL

Device: ADO II AS (PDA closure)

Interventions

ADO II AS (PDA closure) DEVICE

Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

PDA closure

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a PDA
• PDA ≤ 4mm in diameter
• PDA ≥ 3mm in length
• Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study
• NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

You may not qualify if:

• Weight \< 700 grams at time of the procedure
• Age \< 3 days at time of procedure
• Coarctation of the aorta
• Left pulmonary artery stenosis
• Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
• Intracardiac thrombus
• Active infection requiring treatment at the time of implant
• Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
• Other disease process likely to limit survival to less than six (6) months
• Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (9)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Arnold Palmer Hospital

Orlando, Florida, 32806, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Methodist LeBonheur Healthcare

Memphis, Tennessee, 38105, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.

  PMID: 37587183 DERIVED

• Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, Rockefeller TA, Justino H, Nykanen DG, Zahn EM. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20.

  PMID: 32433821 DERIVED

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Ebony Kargbo
• Organization: Abbott Laboratories

Ebony.Kargbo@abbott.com

612-209-8185

Study Officials

• Evan Zahn, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ADO II AS device

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: June 5, 2017
• Primary Completion: September 25, 2019
• Study Completion: April 5, 2022
• Last Updated: February 11, 2025
• Results First Posted: October 5, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)