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Usefulness of microTEE imaging for Structural Heart Disease procedures


- candidate number21743
- NTR NumberNTR5140
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2015
- Secondary IDsNL49744.100.14 VCMO (METC van Antoniusziekenhuis Nieuwegein)
- Public TitleUsefulness of microTEE imaging for Structural Heart Disease procedures
- Scientific TitleUsefulness of microTEE imaging for Structural Heart Disease procedures
- ACRONYM
- hypothesisEstablishing that microTEE can view the same required anatomical features as TEE and ICE for their respective purposes.
- Healt Condition(s) or Problem(s) studiedHeart diseases
- Inclusion criteria-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
- Exclusion criterianone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 6-okt-2014
- planned closingdate1-apr-2015
- Target number of participants30
- InterventionsLAA closure, PFO closure, TAVI
- Primary outcomequantitaive scoring of qualitative assessments (easy, difficult, impossible) and image quality (poor, good, excellent) to compare microTEE with regular TEE or ICE.
- Secondary outcomenot applicable
- TimepointsThe 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.
- Trial web sitenot applicable
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Swaans
- CONTACT for SCIENTIFIC QUERIESPhD Geert Gijsbers
- Sponsor/Initiator Philips Healthcare
- Funding
(Source(s) of Monetary or Material Support)
Philips Health Care
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-mrt-2015 - 1-mei-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl