N/A
N=20
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
Syncope · Syncope, Vasovagal
Bottom Line
View on ClinicalTrials.gov: NCT06038708 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Heart Rate [Bpm] at Specific Time-points During Head-up Tilt Test (HUTT) Examination — 70; 88; 105; 95 beats per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Biotronik SE & Co. KG
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate [Bpm] at Specific Time-points During Head-up Tilt Test (HUTT) Examination |
70; 88; 105; 95 | — |
| PRIMARY Systolic Blood Pressure at Specific Time-points During Head-up Tilt Test (HUTT) Examination |
143; 108; 99; 63 | — |
| PRIMARY Stroke Volume [ml] at Specific Time-points During Head-up Tilt Test (HUTT) |
54.6; 47; 77.9 | — |
| PRIMARY Peripheral Resistance [Dyn·s/cm5] at Specific Time-points During Head-up Tilt Test (HUTT) |
1262.5; 1226.2; 1183.8 | — |
| PRIMARY Time of Maximum Spontaneous Heart Rate |
22.7 | — |
| PRIMARY Time of Pacing Onset |
22.9 | — |
| PRIMARY Time of Recovery of Spontaneous Rhythm After Pacing |
29.2 | — |
| PRIMARY Time of Syncope |
24.0 | — |
| PRIMARY Time of Tilt-down |
25.3 | — |
| PRIMARY Duration of the Recovery Phase [Minutes] |
5.0 | — |
| PRIMARY Slope in Heart Rate [Bpm/Minute] During the Recovery Phase |
-6.0 | — |
| PRIMARY Slope in Systolic Blood Pressure (mmHg Per Minute) During the Recovery Phase |
6.2 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT06038708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.