An observational study in Syncope, Pacemaker and Asystole, sponsored by Azienda Ospedaliera di Bolzano. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Azienda Ospedaliera di Bolzano · Observational
Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study.
Syncope is a common leading affection and is responsible for 1-3% of the presentations in emergency departments and up to 3% of inpatient admissions. Syncope poses often a diagnostic and therapeutic challenge for the attending physician and is often misdiagnosed or underdiagnosed. Patients can be treated with pacemaker implantation when the syncope cause is a cardioinhibition with documented asystole during the syncopal event. When accurately selected, patients benefit from pacemaker therapy with a significant reduction of syncope recurrence in the follow up. However, a substantial portion of the patients (approx. 25%) experience recurrence of syncope despite optimal pacemaker therapy. The underlying mechanism is not well understood and object of the current study.
The main target of the study is to evaluate the time elapsed between the T-LOC during Video Tilt Table Testing and the asystole at the ECG using a registry and to assess its predictive value in patients undergoing invasive treatment. The hypothesis is that a vasodepressive component could lessen the effect of pacing in a patient, leading to cerebral hypoperfusion and syncope despite maintaining a stable rhythm.
This is a prospective, multi-center observational study with 2 year follow-up of patients. Patients eligible for invasive treatment of reflex syncope are included.
If after guideline-directed implantable loop recorder insertion no cardioinhibition has been recorded, the patient is included automatically in the registry.
201 studies on the registry are indexed under Syncope; 36 are open to participants now.
This study's planned enrollment of 64 is below the median of 250 across 84 observational studies indexed under Syncope.
Browse Syncope studies →Azienda Ospedaliera di Bolzano is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by neurally mediated syncope eligible for invasive treatment according to the ESC Guidelines for pacing 2021
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Tilt Table Test
The main goal of the study is to evaluate the time elapsed between the T-LOC during Video Tilt Table Testing and the asystole at the ECG using a national registry and to assess its predictive value in patients undergoing invasive treatment. The hypothesis is that a vasodepressive component could lessen the effect of pacing in a patient, leading to cerebral hypoperfusion and syncope despite maintaining a stable rhythm.
SALT (Syncope-Asystole Latency Time)
• Syncope to asystole latency time (SALT) and its prognostic value regarding freedom of syncope recurrence after pacemaker implantation
Time frame: From enrollment to end of treatment 2 weeks
Recurrence of syncope
• Recurrence of syncope in patients treated with different pacemaker configurations (DDD-CLS, DDD-RDR, DDDrr) and Neurocardioablation
Time frame: From enrollment to treatment end 24 months
Recurrence of syncope
• Recurrences of syncope in treated patients selected by CSM or loop recorder and negative or positive vasodepressive VTTT
Time frame: 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
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Azienda Ospedaliera di Bolzano