structural heart disease Valvular heart disease
Conditions
Interventions
Additional recordings with MicroTEE probe prior to the scheduled procedure
which is currently guided by TEE or ICE will be made
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Subjects who will be undergoing a cardiac intervention where routinely TEE or ICE imaging is used • Subjects who will be subject to a procedure where atrial transseptal puncture is required • Subjects who will undergo a LAA (left atrial appendage) closure procedure • Subjects who will undergo a PFO (patent fossa ovalis) closure procedure • Subject who are 18 years of age or older • Subject who will give informed consent to participate in the study
Exclusion criteria
Exclusion criteria: • Subject is younger that 18 years of age • Subjects who will not give informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this clinical study is: • to establish that microTEE can view the same required anatomical features as TEE and ICE for their respective purposes. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: • to establish that microTEE can be used without the use of general anesthesia • to establish that transnasal use of a S8-3t microTEE probe is feasible • to collect anonymised X-ray fluoroscopy and microTEE data for prototype development of fused X-ray and echography imaging | — |
Countries
Netherlands
Outcome results
None listed