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Completed

NCT Number: NCT02324920

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUS Sherbrooke, Sherbrooke, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DDD-CLS

Device

ODO

Device

Primary outcomes

  1. Patients With Recurrence of Syncopal Episode

    Time frame: 24 months

Secondary outcomes

  1. Patients With Recurrence of Pre-syncope or Syncope

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

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

Acronym: BIOSync CLS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2014
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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