The Effect on EPCs by Successful Cardiac Occlusion Device Implantation

Status Completed

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02957201
Study type	Interventional
Source	University Hospitals of North Midlands NHS Trust
Contact
Status	Completed
Phase	N/A
Start date	July 2016
Completion date	July 31, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01120964` - Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol	Phase 1/Phase 2
Active, not recruiting	`NCT04950192` - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Recruiting	`NCT04291898` - Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study	N/A
Terminated	`NCT01773252` - Right to Left Cardiac Shunt Detection	Phase 3
Not yet recruiting	`NCT06344494` - Cardiac Interventional ICE Imaging Trial	N/A
Not yet recruiting	`NCT05887700` - Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Active, not recruiting	`NCT04105595` - Post Market Registry of the CBSO
Recruiting	`NCT05688670` - Regional Anesthesia Following Pediatric Cardiac Surgery	Phase 4
Active, not recruiting	`NCT02739087` - Radiation-Free Heart Catheterization Using MRI	N/A
Recruiting	`NCT02097758` - Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect	N/A
Completed	`NCT02985684` - Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs	N/A
Not yet recruiting	`NCT06298344` - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease	Early Phase 1
Completed	`NCT06139679` - Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study
Recruiting	`NCT05540769` - Holter and ECG Changes After Transcatheter Closure Of ASD In Children	N/A
Recruiting	`NCT04096924` - A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions	N/A
Enrolling by invitation	`NCT02766569` - International Registry for ASD Closure by Using the Occlutech®Flex II Device in More Than 2000 Patients	N/A
Recruiting	`NCT02453451` - The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics	N/A
Completed	`NCT00498446` - Magnetic Resonance Imaging of Atrial Septal Defects
Not yet recruiting	`NCT06236776` - AWARE Registry: Wearable ECG in Structural Heart Interventions

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect on EPCs by Successful Cardiac Occlusion Device Implantation — EPIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms