NCT04303793

Brief Summary

To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 7, 2020

Last Update Submit

March 9, 2020

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

  • Procedural safety

    studying the occurrence of catheter related complications including 1. Occurrence of vascular access hematoma(Yes/No ) 2. Occurrence of contrast induced nephropathy (Yes/No) 3. PDA closure Device embolization (Yes/No) 4. Cardiac tamponade (Yes/No)

    one month

  • Procedural efficacy

    timing of complete closure of the PDA with no residual shunts 1. Residual left to right shunt (Yes/No) 2. Degree of the residual shunt (Trace, Mild , Moderate, severe) 3. Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )

    one month

  • Procedural outcomes

    comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)

    one month

Interventions

Percutaneous PDA closureDEVICE

transcatheter patent ductus arteriosus closure

Eligibility Criteria

Age1 Month - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients who are candidate for transcatheter PDA closure

You may not qualify if:

  • Patients with PDA dependent pulmonary circulation.
  • Patients with small sized PDA which is silent by auscultation
  • Patients with large sized PDA which is unsuitable for Trans-catheter closure
  • Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
  • Patients with active infection or active infective endarteritis.
  • Patients refusing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed Mohamed Moheb El-Din

CONTACT

01060964666ahmedmoheb34567@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of cardiovascular medicine

Study Record Dates

First Submitted

March 7, 2020

First Posted

March 11, 2020

Study Start

June 1, 2020

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

March 11, 2020

Record last verified: 2020-03