Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
BIOSync CLS
1 other identifier
interventional
128
6 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedResults Posted
Study results publicly available
November 17, 2021
CompletedNovember 17, 2021
July 1, 2020
4.5 years
December 19, 2014
August 30, 2021
October 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients With Recurrence of Syncopal Episode
24 months
Secondary Outcomes (1)
Patients With Recurrence of Pre-syncope or Syncope
24 months
Study Arms (2)
DDD+CLS
EXPERIMENTALThe pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON.
ODO
PLACEBO COMPARATORThe pacemaker will be programmed in ODO mode.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Milan, 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
AMC Academic Medical Center
Amsterdam, Netherlands
Rijnstate Ziekenjuis
Arnhem, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Santa Marta
Lisbon, Portugal
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
Seville, Spain
Related Publications (2)
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.
PMID: 33279955DERIVEDBrignole 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.
PMID: 28472974DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniele Giacopelli
- Organization
- BIOTRONIK Italiy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 24, 2014
Study Start
October 1, 2015
Primary Completion
April 1, 2020
Study Completion
July 1, 2020
Last Updated
November 17, 2021
Results First Posted
November 17, 2021
Record last verified: 2020-07