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

Not Applicable
Completed
Conditions
Syncope
Registration Number
NCT02324920
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
128
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Patients With Recurrence of Syncopal Episode24 months
Secondary Outcome Measures
NameTimeMethod
Patients With Recurrence of Pre-syncope or Syncope24 months

Trial Locations

Locations (24)

CHUS Sherbrooke

🇨🇦

Sherbrooke, Canada

Pais d'Aix

🇫🇷

Aix-en-Provence, France

Hopital de la Timone

🇫🇷

Marseille, France

Clinique Pasteur

🇫🇷

Toulouse, France

Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico

🇮🇹

Tricase, BA, Italy

Policlinico Consorziale

🇮🇹

Bari, Italy

Ospedale Centrale di Bolzano

🇮🇹

Bolzano, Italy

A.O. Pugliese-Ciaccio

🇮🇹

Catanzaro, Italy

Ospedale San Martino

🇮🇹

Genova, Italy

Azienda Ospedaliera Niguarda Ca' Granda

🇮🇹

Milano, Italy

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CHUS Sherbrooke
🇨🇦Sherbrooke, Canada

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