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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope. Furthermore, not only will be investigated if this system eradicates syncopes, but also if the number of presyncopal episodes is reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold) |
|
| CLS group | Experimental | pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker with Closed Loop Stimulation (CLS sensor) | Device | Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of number of syncopes | Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time reduction to the first syncope | Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope. | 1 year |
| Reduction of the recurrence of presyncopal symptoms |
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Inclusion Criteria:
Patients that fulfill the requirements of the study:
Patients without the following contraindications:
Geographically stable patients and able to attend all follow ups
Patients that have signed the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Barón Esquivias, MD PhD FESC | Spanish Society of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Seville | Sevilla | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31713631 | Derived | Baron-Esquivias G, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R, Morillo CA. Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study. Europace. 2020 Feb 1;22(2):314-319. doi: 10.1093/europace/euz294. | |
| 28958328 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2018 | |
| Reset | Nov 16, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2018 | Nov 16, 2018 |
| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Reduction of the recurrence of presyncopal symptoms: Since the CLS sensor can detect any changes in contractility, and presyncopal symptoms are preceded by a contractility increase, it is thought that CLS group patients will suffer less from these symptoms.
| 1 year |
| Improvement of Quality of Life | Improvement of Quality of Life: Syncope produces uncertainties and fear to the patients. This will be checked if pacemaker implant improves QOL of these patients and if a specific programming scheme influences the outcome. | 1 year |
| Derived |
| Baron-Esquivias G, Morillo CA, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R. Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study. J Am Coll Cardiol. 2017 Oct 3;70(14):1720-1728. doi: 10.1016/j.jacc.2017.08.026. |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |