Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038708
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-09-01
Brief Title:
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
Sponsor:
Biotronik SE Co KG
Organization:
Biotronik SE Co KG
Study Overview
Official Title:
BIOSync-HUTT 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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOSync-HUTT
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 pacing This study aims to add knowledge to better understand the mechanisms underlying recurrent syncopal events and optimal pacing programming
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 relies on recent results from the multicentre randomised double-blinded parallel-design BIOSync trial NCT02324920 The BIOSync study provided evidence of benefit of dual chamber pacing in patients with tilt-induced reflex syncope and confirmed the role of Head-up Tilt Table HUTT test as a diagnostic method for cardiac pacing in reflex syncope The Closed Loop Stimulation CLS is able to measure changes in intracardiac impedance during the systolic phase of each cardiac cycle which are strictly correlated to the increased heart rate and right ventricular contraction speed which are usually present during the pre-syncope phase of the reflex It was hypothesized that an early onset of CLS pacing may be triggered by the compensatory increase in heart rate to counteract vasodilation and pressure drop during the pre-syncope phase of the reflex The BIOSync study showed a 77 reduced risk of syncope in the DDD-CLS group as compared to pacing off The design of the BIOSync study did not allow to assess the specific effect that CLS adds to dual-chamber pacing Despite DDD-CLS pacing 22 of patients had syncopal recurrence in 2 years Further investigations are therefore needed in order to reduce this failure rate Indeed it is still unclear whether syncopal recurrences should be ascribed to dominant vasodilation or if the CLS programmingfunctioning needs optimization to more adequately sustain cardiac output during reflex in these specific cases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None