MicroTEE guided lead extraction.

MicroTEE guided lead extraction. - MicroTEE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42044

Enrollment

Registered

2015-06-09

Start date

2015-07-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

defibrillator or pacemaker lead removal

Interventions

extraction

lead adhesion

MicroTEE

Transoesophageal echocardiography

tricuspid valve

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - subjects who require extraction of (one or more) pace/sense or shock leads. - age > 18 years

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)