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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT06455644 Recruiting - Clinical trials for Cardiovascular Diseases

Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion

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

This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion. After signing the informed consent form, the subjects will be randomly assigned to either the cardiac Computed Tomography (CT) group or the Digital Subtraction Angiography (DSA) group. The operator will select the appropriate LAA occluder size for implantation based on different measurement methods. All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.

NCT ID: NCT06449599 Recruiting - Postoperative Pain Clinical Trials

Rhomboid Intercostal Block in Cardioverter Defibrillator Implantation (ICD)

Start date: June 4, 2024
Phase: N/A
Study type: Interventional

ICD implantation can be painful procedure even under local anesthesia and sedation. In this prospective-randomised study, ultrasound-guided rhomboid intercostal block will be performed to reduce intraoperative and postoperative pain. Also comfort of patients and the cardiologists will be evaluated. In this way, we expect to reduce possible complications and make this procedure more comfortable for patients and clinicians.

NCT ID: NCT06431828 Recruiting - Atrial Fibrillation Clinical Trials

Remote Symptom Review in Patients With Implantable Diagnostic Holter

BIOMONI-DIG
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

NCT ID: NCT06411392 Recruiting - Clinical trials for Ventricular Arrythmia

SBRT for Ventricular Arrhythmia

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.

NCT ID: NCT06409533 Recruiting - Atrial Fibrillation Clinical Trials

Rate Control Efficacy in Atrial Fibrillation With Rheumatic Mitral Stenosis: Lenient vs Strict Rate Control Strategies

RACE-MS
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if different types of heart rate control work to improve the clinical outcomes of patients with atrial fibrillation related to rheumatic mitral stenosis in terms of reducing hospitalizations, improving quality of life, and enhancing physical functional capacities. The two types of heart rate (HR) control are strict (resting HR of 60-80 bpm) versus lenient (resting HR of 81-110 bpm) rate control strategies. The main questions it aims to answer are: - Can lenient versus strict heart rate control reduce rehospitalization in patients with atrial fibrillation and rheumatic mitral stenosis? - Does lenient versus strict heart rate control improve the quality of life (QoL) in patients with atrial fibrillation and rheumatic mitral stenosis? - Does lenient versus strict heart rate control enhance functional capacity in patients with atrial fibrillation and rheumatic mitral stenosis? Researchers will compare strict rate control to lenient rate control to see if a particular rate control strategy is non-inferior to the other. Participants will: - Take standardized drugs as per PERKI (Indonesian Heart Association) guidelines for Atrial Fibrillation, which would be either beta-blockers, digoxin, or in combination. This standardized treatment of Atrial Fibrillation will be monitored once every month to see if the dose needs to be titrated in order to reach targeted heart rate control. - After the target of HR control is reached, the participant will be followed up every two weeks via telephone to check for any signs and symptoms. - Furthermore, after the HR target is reached, the participant will visit the cardiology outpatient clinics once every month for 3 consecutive months to see the clinical outcomes of hospitalization, QoL via SF-36 questionnaire, and functional capacities with 6MWT (6-minute walk test). - Additionally, the cardiac function would be evaluated by echocardiography at the baseline (time of enrollment) and at the end of the follow up period.

NCT ID: NCT06407154 Recruiting - Stroke Clinical Trials

Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study, 2nd Wave

CLIMATE-II
Start date: May 21, 2024
Phase:
Study type: Observational

The CLIMATE-II Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.

NCT ID: NCT06402617 Recruiting - Atrial Fibrillation Clinical Trials

Ablation of Focal Activation in Atrial Fibrillation

RETRO-AF
Start date: April 30, 2024
Phase: N/A
Study type: Interventional

Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF). However, it has not been possible to show similar focal drivers during AF, owing to the limitations of mapping in persistent AF. RETRO-Mapping has been developed as a method to generate activation maps during AF to test the hypothesis that persistent AF is also maintained by focal drivers. RETRO-Mapping is able to locate sites of focal activation that were isolated, intermittent, or recurrent during persistent AF. However, a 30-second segment of AF can have approximately 150 wavefronts in a small area of myocardium. Screening for focal activation and manually validating these prior to ablation was not feasible using current commercial systems. RETRO-Mapping can automatically detect focal activation and a recording system that enables the intracardiac signals to be directly analysed by the RETRO-Mapping software. This will allow RETRO-Mapping to build a detailed classification of focal activation types and study the impact of ablation of these sites on the AF cycle length, to address the hypothesis that persistent AF is maintained by focal drivers.

NCT ID: NCT06388629 Recruiting - Arrythmia Clinical Trials

Epicardial Access Study With Rook

EASY-R
Start date: December 17, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access. Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure.

NCT ID: NCT06381245 Recruiting - Atrial Fibrillation Clinical Trials

First-time Ablation of Atrial Fibrillation Registry

DIPE
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success. The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.

NCT ID: NCT06359132 Recruiting - Atrial Fibrillation Clinical Trials

mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients.

TeleConvert-AF
Start date: January 1, 2022
Phase:
Study type: Observational

Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV.