Active clinical trials for "Syncope"

The purpose of this study is to determine whether or not the intravenous adenosine test readily identifies patients with unexplained syncope who would benefit from permanent pacemaker implantation.

Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.

This study will examine whether certain procedures that do not involve the use of medications can reduce symptoms of neurocardiogenic syncope (SIN-ku-pe), or a condition involving recurrent fainting. This condition is also known as vasovagal syncope or neurally mediated hypotension. Neurocardiogenic syncope is a disorder of the autonomic nervous system, which controls automatic body functions such as blood pressure, heart rate, and sweating. That system can be affected by medications, conditions of the mind or body, and by a person's surroundings. Researchers in this study wish to learn whether hypnosis, hand exercises, education, or diary keeping can affect the autonomic nervous system and improve symptoms of neurocardiogenic syncope. Patients age 18 or older who have neurocardiogenic syncope may be eligible for this study. Those who have a medical illness making it unsafe to participate, who cannot discontinue certain medications, or who are pregnant are not eligible. Patients will undergo a medical history and physical examination, complete a questionnaire, and experience Valsalva and tilt table tests. These tests will take about 5 hours during 1 to 2 days. The Valsalva test evaluates some of the reflexes of autonomic nervous system. Patients will lie flat on a padded table and have sensors placed on the body, to measure blood pressure, breathing rate, and other functions. They will blow into a sterile tube for 12 seconds while the body's responses are measured. The procedure may need to be repeated several times. During the test, an intravenous tube, guided by a needle, will be placed in the patient's arm. The tube will be used to collect samples of blood (less than 7 tablespoons) to measure chemicals such as adrenaline. For the tilt table test, a patient will lie on a padded, motorized table and have sensors placed on the body. Velcro straps will be placed around the patient's body to help hold him/her on the table. Then the table will tilt the patient from a flat position to an upright one in about 10 seconds. The patient will stay upright for 45 minutes while symptoms are monitored, measurements are taken, and blood samples are collected through the intravenous tube. Then the table will be returned to the flat position. If the patient faints or is about to faint, or if he or she has an unsafe heart rhythm before the 45 minutes is over, the test will be stopped and the table will be returned to the flat position. Symptoms will be treated as needed. Patients who qualify for further study will then become familiar with hypnosis and be evaluated for their natural ability for experiencing it. A professionally trained doctor will guide patients into a hypnotic state, and patients will be asked to respond to various suggestions. They will be videotaped, an activity that will require a separate consent form. Following these procedures, patients will be assigned to one of the four groups in this study. Those in the hypnosis group will have weekly sessions for 6 weeks, with each session lasting about 1-1/2 hours. The education group will meet a study investigator for learning about syncope and the autonomic nervous system, with each session lasting about 1-1/2 hours once a week for 6 weeks. The hand exercise group will be taught certain hand exercises to perform, at home and as instructed, for 6 weeks. The diary group will receive instructions on keeping a diary pertaining to their condition, at home, for 6 weeks. After 6 weeks, patients will return for an evaluation to include completion of questionnaires and another tilt table test and blood collection by intravenous tube. This entire study will take about 8 weeks. There may be direct benefits from participating in this study. The experimental procedures may help patients' neurocardiogenic syncope. After completing this study, patients will be offered any or all of the experimental procedures tested in this study upon their request and at the discretion of the principal investigator. For example, a patient who is assigned to the diary group may be offered hypnosis, education, and hand exercise instruction after completion of the study.

The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

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.

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. Before CNA: Detailed history taking and assessment of eligibility Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment 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). 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 Assessment of quality of life using the SF-36 questionnaire Implantable Loop Recorder (ILR) implantation 2-3 days before CNA During CNA: Heart rate before and immediately after CNA Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP. 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 Atropine test (2 mg) will be repeated immediately after CNA. After CNA: 1-2 days after CNA standard ECG 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. CNA performed with technique used in the present study is effective in > 90% of patients. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy

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.

Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent aetiology of syncope in young people without apparent cardiac or neurological pathology. It is usually caused by inappropriately trigger-activated cardiac reflex which finally precipitates asystole, sinus bradycardia, or atrioventricular (AV) block [1]. Despite young patients affected by CNS have an excellent prognosis when electro-structural heart diseases are excluded [2], their quality of life may be seriously affected by recurrent episodes [2, 3]. Cardiac pacing might help to control symptoms and therefore is considered in patients aged more than 40 years old with recurrent episodes and documented cardioinhibitory response [1, 4]. In young individuals, the role of cardiac pacing is dubious due to predicted frequent device substitutions and adverse ventricular remodeling over time. Recently, radiofrequency (RF) biatrial ablation of ganglionated plexi (GP) has showed promising results in the short and long-term treatment of reflex syncope, functional atrioventricular block, or sinus node dysfunction [5, 6]. Nonetheless, strong evidences are emerging about efficacy of transcatheter ablation limited to ganglionated plexi in the right atrium with the possibility to avoid side-effects related to left-sided procedures [6] Aim of study To evaluate in a large cohort of patients effectiveness and safety of gangliar transcatheter ablation in the right atrium to obtain atrial denervation and prevent CNS. Study population and methods Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study. Inclusion criteria: age between 18 and 60 years 3 syncopal episodes at least of likely CNS in the previous 2 years marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration [7]. Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope. Exclusion criteria: documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%) documented tachyarrhythmias as possible causes of symptoms channelopathies (Brugada syndrome, LQT or SQT syndrome) ventricular preexcitation symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement pregnancy in women previous cardiac pacemaker implantation. After obtaining informed consent patients will undergo to basal electrophysiological study (EPS) to record AH interval, HV interval, Wenckebach cycle length, sinus node recovery time (SNRT) and correct sinus node recovery time (cSNRT); the same parameters will be recorded immediately after ablation. Following basal EPS an accurate (200 valid points at least) electroanatomic right atrium mapping (CARTO 3™ Biosense Webster, Inc) will be performed and subsequently radiofrequency delivered at right atrial anatomic sites where the underlying presence of ganglionated plexi (GPs) clusters was regarded as highly probable, on the basis of anatomical studies [8-11]: the supero-posterior area (superior right atrial GP, adjacent to the junction of the superior vena cava and the posterior surface of RA), the middleposterior area (posterior right atrial GP, posterior surface of the RA adjacent the interatrial groove), the infero-posterior area (inferior right GP placed between the inferior vena cava, coronary sinus ostium, and near the atrioventricular groove). Transcatheter ablation will be performed using an 8mm-tip catheter (Biosence-Webster Navistar DS 8mm) or an irrigated 4 mm-tip catheter with force control system (Biosence Webster Smarttouch). Ablation will be performed until complete elimination of local atrial electrical activity. Response to radiofrequencies delivery will be considered successful in case of asystolic pause or cardiac cycle lengthening of 30% (compared to basal cycle) at least. To prolong RF delivery despite asystolic response, a quadripolar catheter will be positioned in right ventricle to backup stimulation. To avoid phrenic nerve injury, high amplitude stimulation will be performed just before radiofrequency delivery to the superior right atrial GP. HRV analysis will be performed on admission, at 2 hour after ablation and patients discharge. The HRV analysis will include the following parameters: mean, maximal and minimal heart rate, SDNN (standard deviation of Normal-Normal), RMSSD (root mean square successive difference), pNN50 (percentage of differences between adjacent N-N intervals that are >50 msec), LF (low frequency), HF (high frequency). Moreover, an HUT and an HRV analysis will be performed at 1, 3, 6 and 12 months after ablation procedure during the follow up.

The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the treatment of neurocardiogenic syncope (NCS), also known as "vaso-vagal" syncope. Syncope is a general term for passing out spells and neurocardiogenic syncope is a specific form of passing out spells caused by sudden drops in heart rate or blood pressure. Although the specific mechanisms of NCS are not well understood, it is believed that some people are prone to developing passing out spells in specific situations such as standing up for a long period of time, pain or nausea. In these situations, the body reacts with a paradoxical reflex which leads to a drop in blood pressure and heart rate and causes passing out. Certain types of medications are used to treat NCS including beta-blockers, midodrine and florinef, among others. However, none of these medications are particularly effective at preventing passing out spells and many people continue to have episodes despite trying different medications. Cardioneuroablation is a new form of treatment for NCS. The term ablation means using a wire to make small electrical burns in the heart. Ablation has been used for many years to treat other electrical disturbances in the heart but the use of ablation to treat NCS is a new application. The goal of cardioneuroablation is to identify areas within the heart which are believed to initiate the reflex which triggers the drop in heart rate and blood pressure that leads to passing out. In preliminary studies, it has been suggested that cardioneuroablation may be significantly more effective than medications at preventing passing out spells for people with NCS. Hypothesis: Cardioneuroablation of vagal inputs in the left atrium may serve as an effective treatment modality for the prevention of NCS by blunting the initial trigger of the cascade that leads to symptoms and syncope.

Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.