SyncopeBIOSync CLSNCT02324920
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
A study testing DDD-CLS and ODO in people with Syncope, run by Biotronik SE & Co. KG at 24 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- DDD-CLS and ODO
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 24 sitesin 6 countries
- Study dates
- Oct 2015to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Italy12 sites
Policlinico Consorziale
Bari
Ospedale Centrale di Bolzano
Bolzano
A.O. Pugliese-Ciaccio
Catanzaro
Ospedale San Martino
Genova
Azienda Ospedaliera Niguarda Ca' Granda
Milan
A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"
Naples
Azienda Ospedaliera Universitaria Federico II
Naples
A.O.U. San Luigi Gonzaga
Orbassano
AO di Parma
Parma
Arcispedale Santa Maria Nuova
Reggio Emilia
Policlinico Casilino
Roma
Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico
Tricase, BA
Spain4 sites
Hospital De Bellvitge
Barcelona
Hospital Universitario Vall d'Hebròn
Barcelona
Hospital Universitario Nuestra Senora de la Candelaria
Santa Cruz
Hospital Virgen del Rocio
Seville
France3 sites
Pais d'Aix
Aix-en-Provence
Hopital de la Timone
Marseille
Clinique Pasteur
Toulouse
Netherlands3 sites
AMC Academic Medical Center
Amsterdam
Rijnstate Ziekenjuis
Arnhem
Zuyderland Medisch Centrum
Heerlen
About this study
Official title: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
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.
- Conditions
- Syncope
- Being tested
- DDD-CLS, ODO
- Keywords
- Syncope, Closed Loop Stimulation, CLS
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDD-CLSDevice
ODODevice
| Study group | Role | What they receive |
|---|---|---|
| DDD+CLS | Experimental | The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. Receives: Device: DDD-CLS |
| ODO | Placebo comparator | The pacemaker will be programmed in ODO mode. Receives: Device: ODO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Recurrence of Syncopal Episode
Measured: 24 months
Secondary outcomes (1)
Patients With Recurrence of Pre-syncope or Syncope
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2015
- Primary completionApr 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324920
- Sponsor's protocol ID
- BA103
- Acronym
- BIOSync CLS
- Status last verified
- Jul 2020
- First submitted
- 19 Dec 2014
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33279955Brignole 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.
PubMed 28472974
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.
- ClinicalTrials.gov ID
- NCT02324920
- Acronym / sponsor ID
- BIOSync CLS / BA103
- Conditions
- Syncope
- Keywords
- Syncope, Closed Loop Stimulation, CLS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDD+CLS | Experimental | Device: DDD-CLSThe pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. |
| ODO | Placebo comparator | Device: ODOThe pacemaker will be programmed in ODO mode. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines
- overt heart failure;
- ejection fraction (LVEF) <40% (Echo-assessed within 3-month prior to study participation);
- myocardial infarction;
- diagnosis of hypertrophic or dilated cardiomyopathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDD-CLS | Device | DDD+CLS |
| ODO | Device | ODO |
Primary outcome
Patients With Recurrence of Syncopal Episode
Time frame: 24 months
1 secondary outcome
Patients With Recurrence of Pre-syncope or Syncope
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33279955Brignole 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.
- Derived from this study: PubMed 28472974Brignole 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.
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDD-CLS and ODO in people with Syncope, run by Biotronik SE & Co. KG at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Spain, France, Netherlands, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients With Recurrence of Syncopal Episode (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.