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Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope

Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02324920
Acronym
BIOSync CLS
Enrollment
128
Registered
2014-12-24
Start date
2015-10-31
Completion date
2020-07-31
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

Keywords

Syncope, Closed Loop Stimulation, CLS

Brief summary

The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.

Interventions

DEVICEDDD-CLS
DEVICEODO

Sponsors

Biotronik SE & Co. KG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria: * age \>=40 years * significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year. * type 2B cardio-inhibitory response to TT (according to the VASIS classification). * Alternative therapies have failed or were not feasible. * exclusion of other possible competitive causes of syncope.

Exclusion criteria

\- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines Any cardiac dysfunctions possibly leading to loss of consciousness: * overt heart failure; * ejection fraction (LVEF) \<40% (Echo-assessed within 3-month prior to study participation); * 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; * bundle-branch block; * rapid paroxysmal supraventricular tachycardia or ventricular tachycardia; * preexcited QRS complexes; * prolonged QT interval; * Brugada syndrome; * arrhythmogenic right ventricular cardiomyopathy * Symptomatic orthostatic hypotension diagnosed by standing BP measurement; * Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy). * Symptomatic cardioinhibitory carotid sinus hypersensitivity.

Design outcomes

Primary

MeasureTime frame
Patients With Recurrence of Syncopal Episode24 months

Secondary

MeasureTime frame
Patients With Recurrence of Pre-syncope or Syncope24 months

Countries

Canada, France, Italy, Netherlands, Portugal, Spain

Participant flow

Participants by arm

ArmCount
Active Pacing (DDD+CLS)
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. DDD-CLS
63
Inactive Pacing (ODO)
The pacemaker will be programmed in ODO mode. ODO
64
Total127

Baseline characteristics

CharacteristicInactive Pacing (ODO)Active Pacing (DDD+CLS)Total
Age, Continuous63 years63 years63 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
64 Participants63 Participants127 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
27 Participants18 Participants45 Participants
Sex: Female, Male
Male
37 Participants45 Participants82 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 640 / 64
other
Total, other adverse events
20 / 6439 / 64
serious
Total, serious adverse events
4 / 644 / 64

Outcome results

Primary

Patients With Recurrence of Syncopal Episode

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active Pacing (DDD+CLS)Patients With Recurrence of Syncopal Episode10 Participants
Inactive Pacing (ODO)Patients With Recurrence of Syncopal Episode34 Participants
p-value: <0.00195% CI: [0.11, 0.46]Regression, Cox
Secondary

Patients With Recurrence of Pre-syncope or Syncope

Time frame: 24 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Active Pacing (DDD+CLS)Patients With Recurrence of Pre-syncope or Syncope24 Participants
Inactive Pacing (ODO)Patients With Recurrence of Pre-syncope or Syncope40 Participants
p-value: 0.00295% CI: [0.27, 0.75]Regression, Cox

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026