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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT05526170 Recruiting - Atrial Fibrillation Clinical Trials

Triggers and Risk Factors for Recurrence of Atrial Arrhythmias With the Use of Long-term Monitoring

TriggersAF
Start date: August 1, 2021
Phase:
Study type: Observational

A prospective cohort study to evaluate the association between various triggers encountered in daily life and induction of atrial arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia and premature atrial contractions) with the use of long-term monitoring devices. The collected data of personalized triggers and risk factors will be used to define the individual phenotype of atrial arrhythmia.

NCT ID: NCT05521451 Recruiting - Atrial Fibrillation Clinical Trials

Clinical Cohort Study - TRUST

TRUST
Start date: March 17, 2021
Phase:
Study type: Observational [Patient Registry]

The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.

NCT ID: NCT05508880 Recruiting - Cardiac Arrhythmia Clinical Trials

SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias

SIGIL
Start date: October 30, 2019
Phase:
Study type: Observational

This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.

NCT ID: NCT05498376 Recruiting - Clinical trials for Cardiovascular Diseases

The Leadless AV Versus DDD Pacing Study

LEAVE DDD
Start date: August 23, 2022
Phase: Phase 4
Study type: Interventional

Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems. The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients. The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior VO2 anaerobic threshold compared to the conventional pacemaker arm. Rejection of the null hypothesis is needed to conclude non-inferiority.

NCT ID: NCT05488470 Recruiting - Clinical trials for Arrhythmias, Cardiac

QT Changes as Detected From LINQ ECG During and After Antiarrhythmic Loading (LINQ QT)

LINQ QT
Start date: January 31, 2023
Phase:
Study type: Observational

The LINQ QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical study investigating QT interval changes due to antiarrhythmic drug loading.

NCT ID: NCT05473702 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Smart Textile Sensor System for Health Monitoring

Start date: October 23, 2014
Phase:
Study type: Observational

The present study will investigate a set of biomedical sensors with a wireless data communication system and evaluate the sensors' recording quality. The sensors and wearable wireless system have been approved by Food and Drug Administration (FDA) for recording Electrocardiography (ECG), Trans Thoracic Impedance (TTI), Heart Sounds and Acitigraphy. The sensors and wireless system will be used along with conventional sensor systems (as intended to be used).

NCT ID: NCT05463614 Recruiting - Arrhythmia Clinical Trials

Population Pharmacokinetics of Propafenone and Propranolol in Children Patients

Start date: February 1, 2019
Phase:
Study type: Observational

The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.

NCT ID: NCT05439031 Recruiting - Clinical trials for Ventricular Tachycardia

StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2

STARNL-2
Start date: May 19, 2023
Phase: N/A
Study type: Interventional

Ventricular tachycardia (VT) is a malignant cardiac arrhythmia subjecting our patients to a high risk of sudden death, increased morbidity and reduced quality of life. Unfortunately, failure of treatment is common and VT recurrences remain an important concern. In these patients, stereotactic arrhythmia radiotherapy appears to be an effective and safe treatment. The mechanism of action however remains unknown and should be elucidated. The objective of this phase 2, single arm, monocenter, pre-post intervention study is to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.

NCT ID: NCT05437926 Recruiting - Arrhythmia, Cardiac Clinical Trials

A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients

Start date: April 21, 2022
Phase:
Study type: Observational

The purpose of this study is to describe the Huawei'ssoftware ("Arrhythmia Analysis Software") for the detection of atrial fibrillation, premature beats, and sinus rhythm using photoplethysmography (PPG). Data derived from a wearable device with a PPG sensor (watch or band) in patients with light skin or dark skin tones will be used as an index test. The Huawei software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.

NCT ID: NCT05418036 Recruiting - Clinical trials for Ventricular Arrythmia

Safety Assessment for Sotalol Protocol in Outpatient Unit

Sotalol
Start date: October 26, 2020
Phase: Phase 4
Study type: Interventional

Sotalol is an antiarrhythmic medication with proven effects for the suppression and prevention of supraventricular and ventricular arrhythmias. Due to its potential proarrhythmic effect, its introduction should be cautious, and several guidelines recommend starting the medication in hospital settings. However, patients at low risk for a proarrhythmic effect start the medication in outpatient units, despite the lack of clinical studies in the literature that demonstrate the safety of introducing the medication outside the hospital environment. This research project aims to assess the safety introduction of sotalol in an outpatient unit basis. Our hypothesis is that outpatient introduction of sotalol is safe for low-risk patients and an electrocardiographic analysis after 2 hours of the first dose of medication is a predictor of electrocardiographic changes found after 72 hours. In this research, serial electrocardiographic analysis with measurements of the QT corrected intervals and its dispersion, as well as clinical and laboratory parameters will be performed in 110 patients.