Atrial Septal Defect Clinical Trial
— EPICOfficial title:
The Effect on Endothelial Progenitor Cells (EPCs) by Successful Cardiac Occlusion Device Implantation
NCT number | NCT02957201 |
Other study ID # | 997 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | July 31, 2017 |
Verified date | November 2016 |
Source | University Hospitals of North Midlands NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen
ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be
identified and reviewed in cardiology clinics. These patients will be placed on waiting list
to undergo the procedure. Patient-participants will be consented on the date of admission for
device closure implantation.
The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and
10 patients undergoing LAA closure. EPC will be measured on the day of the device
implantation, day 0 and prior to discharge on day 1.
Patient participants are admitted overnight after the device closure implantation. Then on
subsequent out patient cardiology research clinic follow appointments on days (3-4) and
(7-8).
Status | Completed |
Enrollment | 40 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18 and over and suitable for cardiac device closure Exclusion Criteria: - Patients unable to give informed consent or attend follow up |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | Staffordshire |
Lead Sponsor | Collaborator |
---|---|
University Hospitals of North Midlands NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of EPC cells per microliter of blood following cardiac closure device implantation | Number of EPC cells per microliter of blood. | day 8 |
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