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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT02587533
Eligibility Criteria:
Inclusion Criteria:
* Implanted device for electrical baroreflex stimulation.
* The patient is a 'responder', i. e. carotid-sinus stimulation causes a drop in systolic arterial pressure by at least 15 mmHg.
* The patient gave informed consent.
Exclusion Criteria:
* The patient is an investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* The mental condition renders the patient unable to understand the nature, scope, and possible consequences of the study.
* The patient is unlikely to comply with the protocol.
* The patient is pregnant or breast-feeding.
* Hypoxic conditions for half an hour are considered harmful, e. g. in patients with shunts.
* History of drug or alcohol abuse.
* Discontinuation of diuretic medication for one day is considered harmful. (Reason: Bladder distension is a sympathoexcitatory stimulus and shortens experimental time. In order to prevent these shortcomings three measures are taken: Dispensation with beverages and diuretics as well as complete bladder voiding immediately before the experiment.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02587533
Study Brief:
Protocol Section:
NCT02587533