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Syncope, Vasovagal clinical trials

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NCT ID: NCT06458140 Recruiting - Syncope, Vasovagal Clinical Trials

Cardioneuroablation and Ventricular Proarrhythmia

Roman4
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in sinus node acceleration and improved atrio-ventricular conduction, which in turn prevents vagally-mediated reflex asystole. However, lack of parasympathetic protection may potentially be proarrhythmic, especially on the ventricular level. Whether this is a real threat is not known. Therefore, the aim of our study is to assess acute effects of CNA-induced total vagal denervation, measured by extracardiac vagal stimulation, on ECG and electrophysiological parameters as well as vulnerability to ventricular arrhythmias. The study group will consist of 50 consecutive patients undergoing CNA in our institution. Cardioneuroablation will be performed in standard manner. The following parameters will be assessed at baseline and after CNA (directly after CNA, after atropine injected after CNA and after isoproterenol bolus injected at the very end of the procedure): QTc interval, QT dispersion, right ventricular action potential duration, right ventricular effective refractory period and susceptibility to complex ventricular arrhythmias using programmed ventricular stimulation.

NCT ID: NCT06440291 Recruiting - Syncope, Vasovagal Clinical Trials

Cardioneuroablation for Reflex Syncope and Exercise Capacity

Roman3
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Cardioneuroablation (CNA) is a new promising method to treat reflex syncope which is due to vagally-induced functional sinus arrest or atrio-ventricular block (AVB). Although the procedure is effective in > 80% of patients, there are potential adverse effects associated with the lack of vagal protection. One of them is increased sinus rate and possible worsening of exercise capacity. However, it is not known how often this happens. Moreover, the most accurate tool to asses exercise capacity - cardiopulmonary exercise testing (CPET), has not yet been used in this group of patients. Therefore, the aim of the study is to assess one-year effects of CNA-induced total vagal denervation on cardiorespiratory fitness in patients undergoing CNA due to reflex asystolic syncope. The study group consists of patients undergoing CNA in our institution. All patients give informed written consent to undergo CNA and to participate in the study (Ethics Committee approval # 22/2024). CNA is performed according to standard protocol used in our institution. A symptom-limited cardiopulmonary exercise (CPET) is performed twice, at baseline (1-2 days before CNA) and after one year of follow-up. Standard CPET parameters are measured. Quality of life is measured using a dedicated questionnaire. Also, a control group of healthy volunteers will undergo CPET to answer the question whether subjects with reflex syncope differ in exercise capacity from healthy people.

NCT ID: NCT06356207 Recruiting - Syncope Clinical Trials

Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study

SALT-TILT
Start date: March 20, 2024
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT06336031 Recruiting - Syncope, Vasovagal Clinical Trials

Impact of Blood Phobia on Fainting Susceptibility

Start date: March 30, 2024
Phase: N/A
Study type: Interventional

The primary purpose of this study is to characterize cardiovascular autonomic function to emotional stimuli (blood-injection-injury phobia [needle phobia]) during an orthostatic (upright) challenge in individuals with and without known needle phobia. It is well established that emotional stress can produce hypotensive (low blood pressure) reactions. Interestingly, these hypotensive reactions to venipuncture (even with minimal blood drawn), insulin injections, finger sticks for blood sugar monitoring, dental care, and vaccinations can affect up to a quarter of adults and appear to be uniquely associated with blood-injection-injury phobia rather than other phobias. These hypotensive reactions can ultimately lead to a vasovagal syncope (fainting) response, and lead to increased avoidance of medical and dental procedures as a result of this phobia. Ultimately, this has severe implications on public health and places additional strain on the Canadian healthcare system. Currently, there is limited understanding surrounding the initiation of this response. Additionally, a comprehensive profile of cardiovascular autonomic function during exposure to provoking stimuli during orthostatic stress has not been captured in the literature. We will test individuals with and without blood-injection-injury phobia using our standard approach while exposing them to emotional stimuli.

NCT ID: NCT06333392 Not yet recruiting - Colorectal Cancer Clinical Trials

Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial

Start date: May 2024
Phase: N/A
Study type: Interventional

Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC: 1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult. 2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier. 3. uEMR is eased. 4. Improved bowel cleansing The goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test. The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination. The project has five main hypotheses: 1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs. 2. TUC increases the rate of complete resection of lesions >= 10mm. 3. TUC reduces the rate of painful colonoscopies and vasovagal reactions. 4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon. 5. TUC reduces the carbon footprint by reduced use of single use accessories. If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres. The trial can be linked to three of the Global Goals: - Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor). - Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening. - Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced.

NCT ID: NCT06331819 Recruiting - Clinical trials for Obstructive Sleep Apnea

Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.

VasOSA
Start date: March 10, 2024
Phase:
Study type: Observational

The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital. The main aims are: - To prospectively obtain demographic and clinical information of patients referred for a sleep study. - To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition. - To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders. - To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking.

NCT ID: NCT06166277 Not yet recruiting - Vasovagal Syncope Clinical Trials

Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry

CNA-FWRD
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.

NCT ID: NCT06159764 Not yet recruiting - Bradycardia Clinical Trials

National Registry of Cardioneuroablation in Recurrent Reflex Syncope

CANVAS-R
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program

NCT ID: NCT06038708 Completed - Syncope Clinical Trials

Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial

BIO|Sync-HUTT
Start date: September 29, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing. This study aims to add knowledge to better understand the mechanisms underlying recurrent syncopal events and optimal pacing programming.

NCT ID: NCT06014346 Not yet recruiting - Vasovagal Reaction Clinical Trials

Prevention of Vasovagal Reactions in First-time Blood Donors Using a Combined PSYchological and Physiological Approach

PREDONPSY
Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The prevention of vasovagal reactions (VVR) occurring during or after donation is a major issue for the French Blood Establishment (EFS), firstly to guarantee the safety of donors but also to retain them, as this reaction is one of the negative experiences affecting the return to donation. The EVASION study conducted in the Auvergne Rhône-Alpes region (AURA) on 4828 donors representative of the French donor population, reported a beneficial effect of muscle contraction exercises to prevent the occurrence of VVR during donation, while hydric solutions, and even more so isotonic solutions, were likely to decrease the frequency of delayed VVR. These preventive measures have been integrated into the internal guidelines and currently include muscular and breathing exercises and hydration. Nevertheless, the isotonic solution could not be routinely deployed for feasibility and cost reasons. A salty snack could replace the isotonic solution to produce the same effects with better feasibility and acceptability. Furthermore, a significant proportion of discomfort is psychological in origin, related to stress and anxiety which persist despite these measures, particularly in the first-time donor population. These measures, which are mainly focused on the prevention of VVR of physiological origin, are still insufficient and can be optimized and complemented to reduce the occurrence of VVR, especially in first-time donors for whom anxiety and stress play an important role in the etiology of VVR. Two measures could further reduce the occurrence of VVR: - Reinforcement of the physiological strategy: ingestion of a salty snack before donation, the effect of which could be similar to the effect of the isotonic solution, which could not be delivered in practice because of its cost following the data of the EVASION study. - Addition of a psychological strategy: flyer given at the interview presenting the four most frequent fears as well as a description of the recommended muscular and respiratory exercises, followed by the execution of the recommended exercises before the sampling. Hypothesis is that the combination of a psychological and physiological strategies would allow a reduction of the occurrence of immediate and/or 48 h delayed VVR during the whole blood donation in first time donors compared to the current practices.