The study is intended to (1) confirm the reduced x-ray shadow of the MicroTEE (S8-3t) probe, and to asses whether this results in a more delayed first pull back or a reduction in the number of pull backs or not; and (2) to evaluate the feasibility…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Covering of the lead by the shadow of the TEE probe on fluoroscopic X-ray (in
AP view). Score: no covering, slight covering (no pullback needed), significant
covering (probe pull back necessary).
- Image quality assessment of intraoperative microTEE, sufficient for detection
of complications such as pericardial effusion, tamponade, myocardial
perforation and vascular laceration (score: good or bad. If bad: switch probe
if microTEE was used).
- Time delay to first pull back (in min, from first attempt to pull the lead
after insertion of a normal stilet).
- The number of TEE probe pull backs and reinsertions.
- Quantification of image quality of 3D MicroTEE reconstructions, compared to
3D TTE and conventional 3D TEE images. (Image quality score of the 3D MicroTEE
reconstructions compared to 3D TTE/conventional 3D TEE : better, similar,
worse)
Secondary outcome
- Location of assumed lead adhesions in preoperative 3D TTE/TEE (subclavian
vein, innominate vein, superior caval vein, atrial or ventricular wall,
tricuspid valve).
- Severity of pre- and post-procedural TR (score: 0: no TR, 1: mild TR, 2:
moderate TR, 3: moderate to severe, 4: severe) and calculation of increase in
severity of TR.
- Correlation between the surface of the tricuspid valve tissue present on the
lead after extraction and (1) pre- and periprocedural TEE assumed lead
adhesions, (2) attempts made to adapt the extraction technique, and (3) the
increase in the severity of the TR.
Background summary
Lead extraction can be a complex procedure, associated with multiple
periprocedural complications due to significant lead adhesions to the
surrounding tissues. The large x-ray shadow of the conventional adult-TEE probe
(S7-2t Omni or 3D X7-2t) often requires pull back of the probe in order to
obtain an optimal fluoroscopic view on the leads during extraction. Such pull
backs can be potentially harmful for the patient as it implicates that
potential critical complications, such as tamponade, might not be observed
immediately. In addition, retracting and reinserting of the probe can cause
oesophageal abrasion or even perforation. Furthermore, intraoperative 3D TEE
imaging may be an excellent modality to visualize adhesions, especially at fast
moving structures such as the tricuspid valve (TV), potentially enabling the
physician to adapt his/her extraction technique and to avoid additional
valvular damage or other complications.
Study objective
The study is intended to (1) confirm the reduced x-ray shadow of the MicroTEE
(S8-3t) probe, and to asses whether this results in a more delayed first pull
back or a reduction in the number of pull backs or not; and (2) to evaluate the
feasibility and additional value of both 2D and 3D MicroTEE (S8-3t) images in
determining focal regions of lead wire adhesion, diagnosing complications, and
assessing or reducing the deterioration of tricuspid valve regurgitation in
adults.
Primary Objectives:
- To confirm the reduced fluoroscopic X-ray shadow of the MicroTEE (S8-3t)
probe on the underlying structures/tissues when compared to the conventional 3D
TEE (X7-2t) probe.
- To determine if using the MicroTEE (S8-3t) probe results in a more delayed
first pull back and/or a reduced number of probe pull backs when compared to
the conventional 3D TEE (X7-2t) probe.
- Reconstruction of 3D images from 2D MicroTEE data sets and quantification of
image quality of 3D reconstructions, compared to 3D TTE and 3D TEE.
Secondary Objectives:
- To evaluate the feasibility and additional value of both 2D and 3D MicroTEE
(S8-3t) images in determining focal regions of lead wire adhesion, diagnosing
complications and assessing deterioration of TR in adults.
- To determine if, while pulling the lead after liberating it from any vascular
adhesions, TEE assessment of tricuspid valve adhesion results in an adapted
extraction technique and a consequently reduced severity of the post procedural
TR.
- Determining any correlation between tricuspid valve tissue present on the
lead after extraction (score: small, medium, large) and (1) pre-procedural 3D
TTE and peri-procedural 2D/3D TEE assumed lead adhesions, (2) attempts made to
adapt the extraction technique, and (3) the increase in the severity of the TR.
Study design
A prospective, randomized, controlled pilot study.
Patients will be randomized between the conventional 3D adult-TEE (X7-2t) or
the MicroTEE (S8-3t) probe.
A study period of 18 months is intended.
Study burden and risks
Patients will be receiving standard care besides the introduction of two
different TEE probes prior to extraction. The additional imaging time will be
less than 15 minutes. Because the MicroTEE prove (S8-3t) is smaller than the
conventrional 3D TEE (X7-2t) probe, we do not expect any additional or more
severe gastrointestinal complications than previously mentioned with the
conventioneel probe (cfr. E9). Up to now, no complicaties have been reported
regarding the MicroTEE probe. The patiënt will not be aware of any probe
changes or additional imaging time as he/she will be under general anesthesia.
There will be no other medical devices or medications than otherwise used
during the intervention for this study.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- subjects who require extraction of (one or more) pace/sense or shock leads.
- age > 18 years
Exclusion criteria
- incapacitated adults
- contraindication for TEE: dysphagia, odynophagia, mediastinal radiation, recent upper gastrointestinal surgery, recent esophagitis, thoracic aortic aneurysm and esophageal pathology (stricture, tumour, diverticulum, varices).
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52070.078.15 |