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Syncope, Vasovagal clinical trials

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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: NCT05782699 Completed - Syncope, Vasovagal Clinical Trials

Detecting Syncope by an Integrated Multisensor Patch-type Recorder

Patch-VD
Start date: June 25, 2021
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess the reliability of a new cuffless patch BP monitor in detecting episodes of hypotensive (pre)syncope during tilt testing.

NCT ID: NCT05782647 Completed - Syncope, Vasovagal Clinical Trials

Wearable Monitor in Patients With Syncope

Watch-VD
Start date: May 25, 2021
Phase: N/A
Study type: Interventional

The main purpose of this study is to assess the reliability of a new patient's self-administered wearable watch-type BP monitor in detecting episodes of hypotensive (pre)syncope. Secondary aim regards the estimation of feasibility of this tool.

NCT ID: NCT05729724 Completed - Syncope Clinical Trials

Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)

SynABPM
Start date: October 5, 2022
Phase:
Study type: Observational [Patient Registry]

SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure

NCT ID: NCT05573178 Completed - Syncope, Vasovagal Clinical Trials

Different Catheter Ablation Strategy in Vasovagal Syncope

Start date: December 26, 2020
Phase: N/A
Study type: Interventional

This study is a prospective, single-center randomized controlled clinical trial. patients with refractory vasovagal syncope were randomly divided into two groups according to the proportion of 1:1. Group A: simple left atrial ganglion plexus ablation (RAGP + LSGP + LLGP + LIGP + RIGP ablation); B group: left atrial ganglion plexus combined with right atrial ganglion plexus ablation (group A + consolidation ablation of RAGP at the junction of right atrial septum and superior vena cava). To clarify the role of RAGP in cardiac autonomic nervous system and the effect of ablation, to establish the standard stragtegy of cardiac nerve ablation.

NCT ID: NCT05319951 Completed - Blood Donation Clinical Trials

Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation

NCT ID: NCT04972123 Completed - Syncope, Vasovagal Clinical Trials

The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope

Start date: July 20, 2021
Phase: Phase 2
Study type: Interventional

Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants were randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.

NCT ID: NCT04772755 Completed - Syncope, Vasovagal Clinical Trials

Presyncope (Syncope) Prevention Study

PS^2
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions that might prevent post-vaccination presyncope, and by extension syncope. The two interventions evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and electronic game); or 2) control (usual care) to assess for acceptability and efficacy. Detailed data were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to assess their acceptability of the intervention.

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: 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