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

Primary Purpose

Syncope

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
DDD-CLS
ODO
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope focused on measuring Syncope, Closed Loop Stimulation, CLS

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHUS Sherbrooke
  • Pais d'Aix
  • Hopital de la Timone
  • Clinique Pasteur
  • Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
  • Policlinico Consorziale
  • Ospedale Centrale di Bolzano
  • A.O. Pugliese-Ciaccio
  • Ospedale San Martino
  • Azienda Ospedaliera Niguarda Ca' Granda
  • A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
  • Azienda Ospedaliera Universitaria Federico II
  • A.O.U. San Luigi Gonzaga
  • AO di Parma
  • Arcispedale Santa Maria Nuova
  • Policlinico Casilino
  • AMC Academic Medical Center
  • Rijnstate Ziekenjuis
  • Zuyderland Medisch Centrum
  • Santa Marta
  • Hospital De Bellvitge
  • Hospital Universitario Vall d'Hebròn
  • Hospital Universitario Nuestra Senora de la Candelaria
  • Hospital Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DDD+CLS

ODO

Arm Description

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

The pacemaker will be programmed in ODO mode.

Outcomes

Primary Outcome Measures

Patients With Recurrence of Syncopal Episode

Secondary Outcome Measures

Patients With Recurrence of Pre-syncope or Syncope

Full Information

First Posted
December 19, 2014
Last Updated
October 21, 2021
Sponsor
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02324920
Brief Title
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope
Keywords
Syncope, Closed Loop Stimulation, CLS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DDD+CLS
Arm Type
Experimental
Arm Description
The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
Arm Title
ODO
Arm Type
Placebo Comparator
Arm Description
The pacemaker will be programmed in ODO mode.
Intervention Type
Device
Intervention Name(s)
DDD-CLS
Intervention Type
Device
Intervention Name(s)
ODO
Primary Outcome Measure Information:
Title
Patients With Recurrence of Syncopal Episode
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Patients With Recurrence of Pre-syncope or Syncope
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHUS Sherbrooke
City
Sherbrooke
Country
Canada
Facility Name
Pais d'Aix
City
Aix-en-Provence
Country
France
Facility Name
Hopital de la Timone
City
Marseille
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
City
Tricase
State/Province
BA
Country
Italy
Facility Name
Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
Ospedale Centrale di Bolzano
City
Bolzano
Country
Italy
Facility Name
A.O. Pugliese-Ciaccio
City
Catanzaro
Country
Italy
Facility Name
Ospedale San Martino
City
Genova
Country
Italy
Facility Name
Azienda Ospedaliera Niguarda Ca' Granda
City
Milano
Country
Italy
Facility Name
A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga
City
Orbassano
Country
Italy
Facility Name
AO di Parma
City
Parma
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Policlinico Casilino
City
Roma
Country
Italy
Facility Name
AMC Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate Ziekenjuis
City
Arnhem
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Facility Name
Santa Marta
City
Lisboa
Country
Portugal
Facility Name
Hospital De Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebròn
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de la Candelaria
City
Santa Cruz
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33279955
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.
Results Reference
derived
PubMed Identifier
28472974
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. Erratum In: Trials. 2017 Jun 8;18(1):269.
Results Reference
derived

Learn more about this trial

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

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