Clinical trial NCT02324920: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
Official title: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Keywords: Syncope
Closed Loop Stimulation
CLS
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patients With Recurrence of Syncopal Episode
timeFrame: 24 months
Secondary outcomes:
measure: Patients With Recurrence of Pre-syncope or Syncope
timeFrame: 24 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS Sherbrooke
city: Aix-en-Provence
country: France
facility: Pais d'Aix
city: Marseille
country: France
facility: Hopital de la Timone
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tricase
country: Italy
facility: Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
state: BA
city: Bari
country: Italy
facility: Policlinico Consorziale
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
city: Catanzaro
country: Italy
facility: A.O. Pugliese-Ciaccio
city: Genova
country: Italy
facility: Ospedale San Martino
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca' Granda
city: Napoli
country: Italy
facility: A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Orbassano
country: Italy
facility: A.O.U. San Luigi Gonzaga
city: Parma
country: Italy
facility: AO di Parma
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Policlinico Casilino
city: Amsterdam
country: Netherlands
facility: AMC Academic Medical Center
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenjuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Lisboa
country: Portugal
facility: Santa Marta
city: Barcelona
country: Spain
facility: Hospital De Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebròn
city: Santa Cruz
country: Spain
facility: Hospital Universitario Nuestra Senora de la Candelaria
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
Study officials:
References:
citation: Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.
citation: Brignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Paredes FA, Deharo JC, Del Rosso A, Hamdan MH, Lunati M, Moya A, Gargaro A; BIOSync Study Steering Committee. Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial. Trials. 2017 May 4;18(1):208. doi: 10.1186/s13063-017-1941-4.