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Syncope clinical trials

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NCT ID: NCT04294524 Recruiting - Clinical trials for Sleep Apnea Syndromes

Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS)

VVS-SAS
Start date: February 22, 2017
Phase:
Study type: Observational

This is a multi-centre, registry-based study whose primary objective is to evaluate the effect of treatment for sleep apnoea syndrome (SAS) on the number of syncope/malaise episodes in a population suffering from both idiopathic, recurrent vasovagal syncope/malaises and SAS.

NCT ID: NCT04252729 Completed - Syncope Clinical Trials

Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Start date: July 27, 2017
Phase: N/A
Study type: Interventional

Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.

NCT ID: NCT04241692 Enrolling by invitation - Syncope Clinical Trials

Comparative Study of the Sternal Patch System With a Conventional Holter Recorder

Start date: November 19, 2020
Phase: N/A
Study type: Interventional

This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.

NCT ID: NCT04229589 Active, not recruiting - Syncope Clinical Trials

Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

SYNCOPACED
Start date: January 1, 2010
Phase:
Study type: Observational [Patient Registry]

Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

NCT ID: NCT04206774 Completed - Syncope Clinical Trials

BIO|STREAM.ICM France

Start date: March 13, 2020
Phase:
Study type: Observational

The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

NCT ID: NCT04200014 Recruiting - Clinical trials for Implantable Loop Recorder

Bradycardia Risk Stratification With Loop Recorder After Syncope

Start date: December 9, 2019
Phase:
Study type: Observational

Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder. In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system

NCT ID: NCT04198220 Completed - Atrial Fibrillation Clinical Trials

BIO|STREAM.ICM Obesity

Start date: September 17, 2020
Phase:
Study type: Observational

The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.

NCT ID: NCT04141891 Completed - Stroke Clinical Trials

Advancing Understanding of Transportation Options

AUTO
Start date: December 12, 2019
Phase: N/A
Study type: Interventional

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

NCT ID: NCT04075084 Recruiting - Atrial Fibrillation Clinical Trials

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

BIOSTREAM-ICM
Start date: October 28, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

NCT ID: NCT04025710 Completed - Syncope Clinical Trials

Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

Start date: October 17, 2019
Phase: N/A
Study type: Interventional

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.