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

Syncope Clinical Trial

— BIOSync CLS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324920
• Other study ID #: BA103
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2020

Study information

• Verified date: July 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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.

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Device:
• DDD-CLS

• ODO

Locations

Country	Name	City	State
Canada	CHUS Sherbrooke	Sherbrooke
France	Pais d'Aix	Aix-en-Provence
France	Hopital de la Timone	Marseille
France	Clinique Pasteur	Toulouse
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	A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"	Napoli
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	A.O.U. San Luigi Gonzaga	Orbassano
Italy	AO di Parma	Parma
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	Policlinico Casilino	Roma
Italy	Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico	Tricase	BA
Netherlands	AMC Academic Medical Center	Amsterdam
Netherlands	Rijnstate Ziekenjuis	Arnhem
Netherlands	Zuyderland Medisch Centrum	Heerlen
Portugal	Santa Marta	Lisboa
Spain	Hospital De Bellvitge	Barcelona
Spain	Hospital Universitario Vall d'Hebròn	Barcelona
Spain	Hospital Universitario Nuestra Senora de la Candelaria	Santa Cruz
Spain	Hospital Virgen del Rocio	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Canada,  France,  Italy,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Recurrence of Syncopal Episode		24 months
Secondary	Patients With Recurrence of Pre-syncope or Syncope		24 months