Utilization of Confocal Microscopy During Cardiac Surgery

Status Completed

Clinical Trial Summary

The investigators propose to translate confocal microscopy for use during open heart surgery. This tool will help discriminate between various types of tissues in the heart during surgery. One of the most feared complication after heart surgery is heart block. This flexible fiberoptic confocal microscope will help discriminate between the various types of tissues in the heart and thus help avoid injury to the conduction tissue during surgery.

Clinical Trial Description

This is an interventional pilot study that proposes to evaluate the safety, logistical feasibility, and technological feasibility of using Fluorescite with fiberoptic confocal microscopy during cardiac surgery to discriminate between cardiac tissue and conduction tissue. During surgery to repair atrial septal defect, diluted Fluorescite will be added to the surface of the heart. The fiberoptic confocal microscope (Cellvizio 100 Series System with Confocal Miniprobe) will be used to record images in several different locations of the heart. The image files will be provided to blinded raters who will attempt to identify whether they contain cardiac tissue or conduction tissue. All subjects will be monitored while they are inpatient after surgery for any adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03189134
Study type	Interventional
Source	Boston Children’s Hospital
Contact
Status	Completed
Phase	Phase 1
Start date	April 2, 2018
Completion date	April 26, 2019

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
Recruiting	`NCT06298344` - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease	Early Phase 1
Recruiting	`NCT06431178` - General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients	N/A
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
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
Completed	`NCT02957201` - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation	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