The primary objective of this Clinical Investigation is to evaluate that micro and mini TEE can view the same required anatomical features as ICE for atrial transseptal puncture guidance.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The inclusion of 40 patients and the off line analysis of the comparison of
micro and mini TEE imaging compared with regular ICE imaging. The off line
analysis will allow the study team (treating physicians with support of Philips
study team members) to evaluate the image quality compared to ICE imaging in
atrial transseptal puncture during AF ablation procedures.
Secondary outcome
-The scoring of the preference of the physician for the type of imaging at the
moment of transseptal puncture.
-The scoring of manipulability of micro or mini TEE probe by discretion of the
physician.
-The scoring of intubation of micro or mini TEE probe in the esophagus of the
patient by discretion of the physician.
-The fusion of anonymized X-ray fluoroscopy and micro TEE / mini TEE for
database built-up to develop a fused X-ray/echography imaging device. The
fusion of both images will allow the study team to develop a better image
quality for use in interventional cardiac procedures.
Background summary
Percutaneous catheter ablation of atrial fibrillation (AF) is a complex
electrophysiological procedure, requiring good understanding of the cardiac
anatomy and access to the left atrium (LA) which is obtained by transseptal
puncture.
Intracardiac echocardiography (ICE) is widely used to facilitate transseptal
puncture, assess the LA and pulmonary vein (PV) anatomy, as well as monitor
accuracy of ablation lesions and complications.
However, ICE is an invasive tool, which requires additional venous puncture.
Also, the cost of a single-use probe is not negligible.
Transoesophageal echocardiography (TEE) has been used for many years to assess
LA anatomy, especially to exclude thrombus in the LA appendage (LAA), and also
to facilitate transseptal puncture. TEE imaging is less invasive than ICE and
use of TEE can lower costs as it can be used many times.
Alternatives to the large TEE probe may be the smaller S8-3t micro TEE probe
and the S7-3t mini TEE probe. Both the micro TEE and mini TEE probes have been
designed for pediatric use, but the intended use of the devices allows usage in
adults depending on image quality needs.
* The micro TEE is smaller than the mini TEE and therefor even usable for
neonates. The introduction of the micro TEE in the esophagus might be easier,
based on the dimensions of the tip of the probe. However, micro TEE is expected
to provide limited image quality and color Doppler flow capability in adults.
* Compared to the S8-3t micro TEE probe, the S7-3t mini TEE probe is expected
to exhibit superior image and color Doppler imaging, also at deeper levels in
adults, based on device specifications.
The aim of the present study is to evaluate the micro TEE and mini TEE for
usability in terms of manipulability and image quality for transseptal puncture
and to gain insight in the capabilities of micro and mini TEE to image selected
LA anatomy that can possibly be used for additional information during AF
ablation procedures. All TEE data will be compared with the routinely used
ICE-catheter.
Study objective
The primary objective of this Clinical Investigation is to evaluate that micro
and mini TEE can view the same required anatomical features as ICE for atrial
transseptal puncture guidance.
Study design
This is a randomized controlled, unblinded, single center study.
Study burden and risks
A released ultrasound product (iE33 + S8-3t microTEE probe + S7-3t mini TEE
probe) will be used within their intended use. A micro or mini TEE ultrasound
examination is considered to be completey harmless and within the applicability
of the safety report of the released iE33,
S8-3t and S7-3t products.
Additional burden:
-The study will prolong the total procedure time, this will be approximately 10
minutes.
-The study will require additional X-ray images. The amount of X-ray radiation
involved is negligible compared to the radiation of the total treatment.
Veenpluis 4-6
Best 5684 PC
NL
Veenpluis 4-6
Best 5684 PC
NL
Listed location countries
Age
Inclusion criteria
-Subjects who will be undergoing a left atrial ablation procedure where routinely ICE imaging is used
Exclusion criteria
-Subject younger that 18 years of age
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53139.044.15 |
| OMON | NL-OMON25982 |