Status:
COMPLETED
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Syncope
Syncope, Vasovagal
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pa...
Detailed Description
The 2021 European Society of Cardiology guidelines recommend cardiac pacing in patients aged \>40 years with tilt-induced asystolic reflex syncope (class I, level of evidence A). The recommendation re...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Ability to understand the nature of the study.
- Willingness to provide written informed consent.
- Patients undergoing HUTT for monitoring of syncope, therapy adjustment, training or other medical reasons during ordinary follow-up, irrespective of study participation
- Patients who participated in the BIOSync study\*.
- Patients with a dual-chamber pacing system equipped with the CLS algorithm. \* If needed, inclusion of other patients who did not participate in the BIOSync study will be considered to complete study cohort, provided that they have already a CLS pacemaker system and fulfill the same inclusion/exclusion criteria of the BIOSync study.
- Exclusion criteria
- Pregnant or breast feeding women.
- Age less than 40 years.
- Patients who after the BIOSync study participation have developed the following:
- Any indication to pacemaker different from reflex syncope with positive HUTT response; or
- Any classified indication to implantable defibrillator, cardiac resynchronization therapy according to current guidelines; or
- Any cardiac dysfunctions likely leading to loss of consciousness (overt heart failure, ejection fraction \<40%, myocardial infarction, diagnosis of hypertrophic or dilated cardiomyopathy, clinically significant valvular disease, sinus bradycardia \<50 bpm or sinoatrial block, Mobitz I second degree atrioventricular block, Mobitz II second or third degree atrioventricular block, complete bundle-branch block).
Exclusion
Key Trial Info
Start Date :
September 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 12 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06038708
Start Date
September 29 2022
End Date
May 12 2023
Last Update
February 3 2025
Active Locations (2)
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1
Ospedale di Bolzano - Azienda Sanitaria dell'Alto Adige
Bolzano, Italy, 39100
2
Monaldi - AORN dei Colli - Università della Campania "Luigi Vanvitelli"
Napoli, Italy, 80131