Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT01821651
Eligibility Criteria:
Inclusion criteria:
* Male and female patients over 18 years of age.
* Ability and willingness to give informed consent.
* Indication for TAVI, MitraClip, catheter ablation or percutaneous closure of the left atrial appendage procedure performed in the hybrid OR suite.
* Recent good quality CTA (TAVI patients only, no CTA needed for EchoNav).
Exclusion criteria:
* Contraindications on ethical grounds,
* Women who are pregnant or breast feeding,
* Emergency cases,
* Contraindication or known hypersensitivity to contrast media which is unresponsive to pretreatment with steroids and antihistamines,
* Known renal insufficiency (GFR \< 50 ml/min) and patient is not on chronic hemodialysis (TAVI patients only, no contrast agent is necessary during MitraClip and transseptal puncture),
* Contraindications for transesophageal Echo (EchoNav patients only, TAVI is possible without TEE and TEE is not needed for the HeartNavigator),
* Known or suspected drug or alcohol abuse,
* Enrollment into a clinical trial within last 4 weeks if overlapping enrolment is not explicitly approved by ethics committee for the two trials,
* Patient is unable or unwilling to cooperate with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01821651
Study Brief:
Protocol Section:
NCT01821651