Status:
COMPLETED
Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy
Lead Sponsor:
CES University
Conditions:
Syncope
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Vasovagal syncope is an entity frequently in the emergency services, its treatment includes pharmacological and non-pharmacological measures, and in some severe cases, requires the implantation of car...
Detailed Description
Syncope is defined as a loss of consciousness with inability to maintain the postural tone, with subsequent spontaneous recovery and without neurological sequelae. This occurs due to cerebral hypoperf...
Eligibility Criteria
Inclusion
- Over 18 years.
- Diagnosis of neurally mediated syncope with a tilting table test (Tilt test) that demonstrates a mixed (type 1) or cardioinhibitory response (Type 2A and 2B).
- Negative impact on work and social life.
- Non-respondent to pharmacological therapy (Fludrocortisone 0.1mg / 24 hours for 3 months) and non-pharmacological (exercise, hydration and consumption of more than 3 months) is due to a cardiologist who has performed a strict stricture over time.
- At least 2 episodes of syncope in the last year.
Exclusion
- Complete atrioventricular block.
- Second degree ventricular atrial block.
- Bradycardia syndrome - tachycardia.
- Disease of the sinus node.
- Arrhythmia (bradycardia or tachycardia that generate syncope and / or low cardiac output).
- Syncope due to hypersensitivity of the carotid sinus.
- Syncope with Tilt Test that demonstrates depressant vasopressor response (type 3).
- Refusal of the patient, his relatives or the attending physician to participate in the study.
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03876652
Start Date
November 22 2017
End Date
March 1 2022
Last Update
March 9 2022
Active Locations (2)
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1
CES Cardiología sede Sandiego
Medellín, Antioquia, Colombia, 05001
2
Clínica CES
Medellín, Antioquia, Colombia, 05001