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

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ClinicalTrials.gov Identifier: NCT02324920
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.

Condition or disease Intervention/treatment Phase
Syncope Device: DDD-CLS Device: ODO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
Actual Study Start Date : October 2015
Actual Primary Completion Date : April 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Experimental: DDD+CLS
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
Device: DDD-CLS
Placebo Comparator: ODO
The pacemaker will be programmed in ODO mode.
Device: ODO



Primary Outcome Measures :
  1. Time to the first recurrence of syncopal episode [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Time to the first recurrence of pre-syncope or syncope, whichever comes first [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324920


Locations
Show Show 24 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02324920    
Other Study ID Numbers: BA103
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Keywords provided by Biotronik SE & Co. KG:
Syncope
Closed Loop Stimulation
CLS
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases