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N/A Completed N=128 Randomized Triple-blind Treatment

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

Syncope
Source: ClinicalTrials.gov NCT02324920 ↗
Enrolled (actual)
128
Serious AEs
6.3%
Results posted
Nov 2021
Primary outcomePrimary: Patients With Recurrence of Syncopal Episode — 10; 34 Participants — p=<0.001

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Patients With Recurrence of Syncopal Episode
10; 34 <0.001 sig
SECONDARY
Patients With Recurrence of Pre-syncope or Syncope
24; 40 0.002 sig

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02324920). 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. Informational only — not medical advice.

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