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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDD+CLS | Experimental | The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. |
|
| ODO | Placebo Comparator | The pacemaker will be programmed in ODO mode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDD-CLS | Device |
| ||
| ODO |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Recurrence of Syncopal Episode | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Recurrence of Pre-syncope or Syncope | 24 months |
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Inclusion Criteria:
Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUS Sherbrooke | Sherbrooke | Canada | ||||
| Pais d'Aix |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33279955 | Derived | 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. | |
| 28472974 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Pacing (DDD+CLS) | The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. DDD-CLS |
| FG001 | Inactive Pacing (ODO) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 20, 2016 | Aug 25, 2021 |
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|
| 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" | Naples | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 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 |
| 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. |
The pacemaker will be programmed in ODO mode.
ODO
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Pacing (DDD+CLS) | The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. DDD-CLS |
| BG001 | Inactive Pacing (ODO) | The pacemaker will be programmed in ODO mode. ODO |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Recurrence of Syncopal Episode | Posted | Count of Participants | Participants | 24 months |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Recurrence of Pre-syncope or Syncope | Posted | Count of Participants | Participants | 24 months |
|
|
median follow-up period of 14.1 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Pacing (DDD+CLS) | The pacemaker will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON. DDD-CLS | 0 | 64 | 4 | 64 | 20 | 64 |
| EG001 | Inactive Pacing (ODO) | The pacemaker will be programmed in ODO mode. ODO | 0 | 64 | 4 | 64 | 39 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subtalar arthrodesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| inguinal hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| NSTEMI | Cardiac disorders | Systematic Assessment |
| ||
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| syncope | Nervous system disorders | Systematic Assessment |
| ||
| pericarditis | Cardiac disorders | Systematic Assessment |
| ||
| lead dislodgement | Cardiac disorders | Systematic Assessment |
| ||
| lead was not properly connected to the pacemaker | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| syncope | Nervous system disorders | Systematic Assessment |
| ||
| presyncope | Cardiac disorders | Systematic Assessment |
| ||
| Keloid formation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| mild pocket bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| unspecified pain around the chest/ pocket. | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| palpitations | Cardiac disorders | Systematic Assessment |
| ||
| inappropriate pacing due to undersensing | Cardiac disorders | Systematic Assessment |
| ||
| chest pain | Cardiac disorders | Systematic Assessment |
| ||
| incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| fatigue (mild obstructive sleep apnea syndrome) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniele Giacopelli | BIOTRONIK Italiy | +39 3491712305 | daniele.giacopelli@biotronik.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2019 | Aug 25, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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