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The Effect on EPCs by Successful Cardiac Occlusion Device Implantation (EPIC)

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: NCT02957201
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

Study Description
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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).


Condition or disease Intervention/treatment Phase
Foramen Ovale, Patent Heart Septal Defects, Atrial Atrial Septal Defect Other: Blood samples Not Applicable

Detailed Description:

The objective of this study is to assess the effect, if any, on EPC count and cardiac device implantation.

All patients awaiting LAA or PFO/ASD occlusion will firstly be reviewed in a cardiology clinic and assessed. Suitable patients will then be placed on a waiting list for occlusion device implantation and therefore identified as potential participants in the study. Patient-participants will be informed of the trial and given a chance to participate, this may be by face to face and or via invitation letter. All patient-participants will be given a copy of the patient information sheet.

Formal consent to participate in the trial will occur on the morning of the procedure. This will avoid repeated visits by patients that may have to travel some considerable distance.

The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD occlusion and 10 patients undergoing LAA occlusion. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1, then on subsequent follow up appointments on days (3-4) and (7-8). Blood samples of 3-5ml will be taken to allow flow cytometric analysis for EPCs.

Standard follow up for participants may include transesophageal echocardiography (TOE) at 3 months after implantation. This will give a direct assessment of device related thrombus. Currently TOE is not standard of care in PFO follow up. If a TOE result is available for either group the investigators will use the results in our study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect on Endothelial Progenitor Cells (EPCs) by Successful Cardiac Occlusion Device Implantation
Study Start Date : July 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017
Arms and Interventions
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Arm Intervention/treatment
Blood samples
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
Blood samples at baseline and 3 timepoints for EPC analysis


Outcome Measures
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Primary Outcome Measures :
  1. Number of EPC cells per microliter of blood following cardiac closure device implantation [ Time Frame: day 8 ]
    Number of EPC cells per microliter of blood.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957201


Locations
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United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
Investigators
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Principal Investigator: Butler Robert University Hospitals of North Midlands NHS Trust
More Information
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Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT02957201    
Other Study ID Numbers: 997
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Foramen Ovale, Patent
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities