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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
DDD+CLS	DDD-CLS	The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
ODO	ODO	The pacemaker will be programmed in ODO mode.

Primary Outcome Measures

Name	Time	Method
Patients With Recurrence of Syncopal Episode	24 months

Secondary Outcome Measures

Name	Time	Method
Patients With Recurrence of Pre-syncope or Syncope	24 months

Locations (24): Rijnstate Ziekenjuis
🇳🇱
Arnhem, Netherlands
Zuyderland Medisch Centrum
🇳🇱
Heerlen, Netherlands
Hopital de la Timone
🇫🇷
Marseille, France
Ospedale San Martino
🇮🇹
Genova, Italy
AMC Academic Medical Center
🇳🇱
Amsterdam, Netherlands
CHUS Sherbrooke
🇨🇦
Sherbrooke, Canada
Pais d'Aix
🇫🇷
Aix-en-Provence, France
Hospital Universitario Vall d'Hebròn
🇪🇸
Barcelona, Spain
Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
🇮🇹
Tricase, BA, Italy
Azienda Ospedaliera Niguarda Ca' Granda
🇮🇹
Milano, Italy
A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
🇮🇹
Napoli, Italy
A.O.U. San Luigi Gonzaga
🇮🇹
Orbassano, Italy
Hospital Universitario Nuestra Senora de la Candelaria
🇪🇸
Santa Cruz, Spain
AO di Parma
🇮🇹
Parma, Italy
Santa Marta
🇵🇹
Lisboa, Portugal
Hospital Virgen del Rocio
🇪🇸
Sevilla, Spain
Clinique Pasteur
🇫🇷
Toulouse, France
Hospital De Bellvitge
🇪🇸
Barcelona, Spain
Arcispedale Santa Maria Nuova
🇮🇹
Reggio Emilia, Italy
A.O. Pugliese-Ciaccio
🇮🇹
Catanzaro, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹
Napoli, Italy
Policlinico Casilino
🇮🇹
Roma, Italy
Ospedale Centrale di Bolzano
🇮🇹
Bolzano, Italy
Policlinico Consorziale
🇮🇹
Bari, Italy