Establishing that microTEE can view the same required anatomical features as TEE and ICE for their respective purposes.
ID
Bron
Aandoening
Structural Heart Disease procedures
PFO
LAA
TAVI
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
quantitaive scoring of qualitative assessments (easy, difficult, impossible) and image quality (poor, good, excellent) to compare microTEE with regular TEE or ICE.
Doel van het onderzoek
Establishing that microTEE can view the same required anatomical features as TEE and ICE for their respective purposes.
Onderzoeksopzet
The endpoint is the inclusion of 30 patients and the off line analysis of the comparison of microTEE imaging and manipulations compared with regular TEE and ICE imaging.
Onderzoeksproduct en/of interventie
LAA closure, PFO closure, TAVI
Publiek
Swaans
Nieuwegein 3435CM
The Netherlands
+31-88-3203000
m.swaans@antoniusziekenhuis.nl
Wetenschappelijk
Swaans
Nieuwegein 3435CM
The Netherlands
+31-88-3203000
m.swaans@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-Subjects who will be undergoing a cardiac intervention where routinely TEE or ICE imaging is used:
* atrial transseptal puncture
* LAA (left atrial appendage) closure
* PFO (patent fossa ovalis) closure
-Subject who are 18 years of age or older
-Subject who will give informed consent to participate in the study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
none
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4893 |
| NTR-old | NTR5140 |
| CCMO | NL49744.100.14 |
| OMON | NL-OMON40823 |