Syncope, VasovagalPhase 4SPAINNCT01621464
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
A Phase 4 study testing Pacemaker with Closed Loop Stimulation (CLS sensor) in people with Syncope, Vasovagal, run by Spanish Society of Cardiology at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Pacemaker with Closed Loop Stimulation (CLS sensor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- May 2006to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 that fulfill the requirements of the study:
- Patients with 5 previous neuromediated syncopes
- Positive Tilt test, Cardioinhibitory response, heart rate < 40 bpm for at least 10'' or pauses > 3''
- Patient ≥ 40 years
- No cardiopathy present
- Patients without the following contraindications:
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- Drug treatment with β-blockers
- Chronic Polyneuropathy
- All contraindications for DDD or DDDR pacing (as per clinical guidelines SEC, 2002)
- Geographically stable patients and able to attend all follow ups
- Patients that have signed the informed consent
Who cannot join
- Patients that do NOT fulfill the inclusion criteria mentioned above
- Patients with the contraindications indicated above
- Patients with syncopes due to Carotid Sinus Hypersensitivity
- Other syncope causes different to the CNS
- Patients involved in other clinical studies
- Pregnant women or in age bearing that are not using at least 2 contraception methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Loop Stimulation for Neuromediated Syncope
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.
- Conditions
- Syncope, Vasovagal
- Being tested
- Pacemaker with Closed Loop Stimulation (CLS sensor)
- Keywords
- Neuromediated syncope, Tilt test, Pacemaker, CLS sensor
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker with Closed Loop Stimulation (CLS sensor)Device
Also called BIOTRONIK, Neuromediated Syncope
Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold) Receives: Device: Pacemaker with Closed Loop Stimulation (CLS sensor) |
| CLS group | Experimental | pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS) Receives: Device: Pacemaker with Closed Loop Stimulation (CLS sensor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of number of syncopes
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
Measured: 1 year
Secondary outcomes (3)
Time reduction to the first syncope
Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
Measured: 1 year
Reduction of the recurrence of presyncopal symptoms
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMay 2006
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Cardiology
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Principal investigator, Gonzalo Barón-Esquivias, MD, PhD, FESC, Spanish Society of Cardiology
- Investigators
- Gonzalo Barón Esquivias, MD PhD FESC, Principal investigator, Spanish Society of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621464
- Sponsor's protocol ID
- SPAIN
- Acronym
- SPAIN
- Status last verified
- Apr 2014
- First submitted
- 11 Jun 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31713631Baron-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.
PubMed 28958328
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Stimulation for Neuromediated Syncope
- ClinicalTrials.gov ID
- NCT01621464
- Acronym / sponsor ID
- SPAIN / SPAIN
- Conditions
- Syncope, Vasovagal
- Keywords
- Neuromediated syncope, Tilt test, Pacemaker, CLS sensor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Spanish Society of CardiologyUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- May 2006
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Pacemaker with Closed Loop Stimulation (CLS sensor)Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold) |
| CLS group | Experimental | Device: Pacemaker with Closed Loop Stimulation (CLS sensor)pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- Patients that do NOT fulfill the inclusion criteria mentioned above
- Patients with the contraindications indicated above
- Patients with syncopes due to Carotid Sinus Hypersensitivity
- Other syncope causes different to the CNS
- Patients involved in other clinical studies
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 |
|---|---|---|
| Pacemaker with Closed Loop Stimulation (CLS sensor)Also: BIOTRONIK, Neuromediated SyncopeCrossover: 1 year at control group and 1 year at CLS group (randomized which group goes first) | Device | CLS group, Control |
Primary outcome
Reduction of number of syncopes
Time frame: 1 year
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
3 secondary outcomes
Time reduction to the first syncope
Time frame: 1 year
Reduction of the recurrence of presyncopal symptoms
Time frame: 1 year
Improvement of Quality of Life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Derived from this study: PubMed 31713631Baron-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.
- Derived from this study: PubMed 28958328Baron-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.
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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.
Gonzalo Barón Esquivias, MD PhD FESC principal investigator
Spanish Society of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pacemaker with Closed Loop Stimulation (CLS sensor) in people with Syncope, Vasovagal, run by Spanish Society of Cardiology at 1 site in Spain.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reduction of number of syncopes (time frame: 1 year). 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 NCT01621464, 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 14 Apr 2014.