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Syncope clinical trials

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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: 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.

NCT ID: NCT03903744 Completed - Syncope, Vasovagal Clinical Trials

Cardioneuroablation for Reflex Syncope

ROMAN
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Aim. To assess the effects of cardioneuroablation (CNA) on cardiac autonomic regulation and syncope recurrences in patients with vasovagal syncope (VVS), and to compare this novel approach with standard non-pharmacological treatment. Measurements. 1. Before CNA: 1. Detailed history taking and assessment of eligibility 2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval 3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment 4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt). 5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value 6. Assessment of quality of life using the SF-36 questionnaire 7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA 2. During CNA: 1. Heart rate before and immediately after CNA 2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP. 3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA 4. Atropine test (2 mg) will be repeated immediately after CNA. 3. After CNA: 1. 1-2 days after CNA standard ECG 2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire Anticipated results. 1. CNA performed with technique used in the present study is effective in > 90% of patients. 2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy

NCT ID: NCT03876652 Completed - Syncope Clinical Trials

Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy

Start date: November 22, 2017
Phase: N/A
Study type: Interventional

Vasovagal syncope is an entity frequently in the emergency services, its treatment includes pharmacological and non-pharmacological measures, and in some severe cases, requires the implantation of cardiac stimulation devices, specifically, those pacemakers that have closed-loop sensors (CLS). This research is an intervention study, multi-institutional, randomized and double blind that will be carried out in patients older than 18 years, with a diagnosis of neurally mediated type 1, 2A or 2B syncope documented in a tilting table test, who have had at least 2 syncope in the last year and that significantly affects the quality of life despite the use of pharmacological and non-pharmacological non-interventionist therapy. This study aims to evaluate the effect of cardiac pacing therapy with CLS pacemakers on quality of life, recurrence of syncope and pre-syncopal symptoms in patients with a diagnosis of neurally mediated syncope in this group of patients.

NCT ID: NCT03850327 Completed - Atrial Fibrillation Clinical Trials

BIO|CONCEPT.BIOMONITOR III

Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.

NCT ID: NCT03803215 Completed - Syncope Clinical Trials

Theophylline for Low Adenosine Syncope

THEO-USA
Start date: May 11, 2016
Phase:
Study type: Observational

The study aims at assessing that theophylline is effective in patients with no prodromes, normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population who have received an implantable cardiac monitor (ICM) for diagnosis of unexplained or atypical reflex syncope.

NCT ID: NCT03786640 Completed - Fatigue Clinical Trials

Abbott Brady 3T MRI PMCF

Start date: October 4, 2019
Phase:
Study type: Observational

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

NCT ID: NCT03721393 Completed - Clinical trials for Orthostatic Hypotension

Data Collection - Of Syncope Tilt Table Testing Study

COST3
Start date: October 4, 2019
Phase:
Study type: Observational

To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device. To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

NCT ID: NCT03720639 Completed - Stroke Clinical Trials

Confirm Rx™ Versus Reveal LINQ™ - Which is More Reliable in Data Transmission? A Randomized Clinical Study

Start date: May 18, 2018
Phase: N/A
Study type: Interventional

This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.