Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 1177 for:    adenosine

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055858
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE June 5, 2017
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • Safety Endpoint: The rate of major complications after an attempted ADO II AS device implant [ Time Frame: Through 180 days ]
    The rate of major complications after an attempted ADO II AS device implant.
  • Effectiveness Endpoint: 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 or Grade 1 shunt by transthoracic echocardiography. [ Time Frame: At the six-month follow-up ]
    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 or Grade 1 shunt by transthoracic echocardiography.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03055858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
Obstruction in left pulmonary artery or aorta: The rate of significant obstruction of the pulmonary artery or aorta [ Time Frame: Through 6 month follow-up visit ]
The rate of significant obstruction of the pulmonary artery or aorta.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMPLATZER Duct Occluder II Additional Sizes
Official Title  ICMJE AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study
Brief Summary

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label study 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
ADO II AS device
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patent Ductus Arteriosus
Intervention  ICMJE Device: ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Study Arms  ICMJE Experimental: PDA closure
Intervention: Device: ADO II AS (PDA closure)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
200
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055858
Other Study ID Numbers  ICMJE SJM-CIP-10171
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evan Zahn, MD Cedars-Sinai Medical Center
PRS Account Abbott Medical Devices
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP