The Effect on EPCs by Successful Cardiac Occlusion Device Implantation

NCT02957201 | Completed

• 1 other identifier: 997
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Foramen Ovale, Patent; Heart Septal Defects, Atrial; Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• Number of EPC cells per microliter of blood following cardiac closure device implantation

  Number of EPC cells per microliter of blood.

  day 8

Study Arms (1)

Blood samples

OTHER

Blood samples taken at baseline, day 1-2, day 3-4 and day 7-8 for Endothelial Progenitor Analysis with flow cytometer

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples at baseline and 3 timepoints for EPC analysis

Blood samples

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and over and suitable for cardiac device closure

You may not qualify if:

• Patients unable to give informed consent or attend follow up

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Foramen Ovale, Patent; Heart Septal Defects, Atrial

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Butler Robert

  University Hospitals of North Midlands NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 7, 2016
• Study Start: July 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: March 14, 2019

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)