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Usefulness of micro TEE and mini TEE imaging for EP procedures

Usefulness of micro TEE and mini TEE imaging for EP procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25982
Enrollment
40
Registered
2015-07-14
Start date
2015-08-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

atrial fibrillation, ablation, EP procedures

Interventions

Transseptal puncture guidance by micro or miniTEE compared to ICE guidance.

Sponsors

Philips Healthcare, Best, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Subjects who will be undergoing a left atrial ablation procedure where routinely ICE imaging is used •Subjects who will be subject to a procedure where atrial transseptal puncture is required •Subject who are 18 years of age or older •Subject who are willing to give informed consent to participate in the study

Exclusion criteria

Exclusion criteria: •Patients unwilling or unable to give informed consent

Design outcomes

Primary

MeasureTime frame
The comparison of micro and mini TEE imaging compared with regular ICE imaging. The off line analysis of the data 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

MeasureTime frame
•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.

Contacts

Public ContactStevenhagen

MST Twente

Y.Stevenhagen@mst.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)