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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT06019845 Recruiting - Clinical trials for Arrhythmias, Cardiac

The MAGiC™ Cardiac Ablation European Study

MAGiC-FEST
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.

NCT ID: NCT06014996 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.

Start date: September 4, 2023
Phase: N/A
Study type: Interventional

This study is a mulitcentre, randomized, parallel-group evaluation of pulse field ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic paroxysmal AF. Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.

NCT ID: NCT06013917 Recruiting - Clinical trials for Arrhythmias, Cardiac

Artificial Intelligence (AI) Enabled, Cloud-based ECG Diagnostic Solution (ZBPro) Feasibility Testing

Start date: August 30, 2023
Phase:
Study type: Observational

The proposed research is to address the accessibility and affordability of technology to capture symptomatic and asymptomatic cardiac events via Long-Term Continuous Electrocardiogram Monitoring (LTCM), and to provide physicians with full access to their patients' recorded data in a timely manner. We adopt an FDA cleared single- lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliant. The patch transmits the recorded data to our cloud-based platform: ZBPro™, where our innovative technologies reside. Our proprietary AI algorithms with innovative human interaction tools, which were developed under the National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I (Award #: 2025951) Award analyze and interpret the recorded data to detect and annotate arrhythmia/cardiac events, and generates daily reports for physician review. The feasibility of our algorithms has been verified using ZBeats' proprietary ECG database based on the standard ANSI/AAMI EC57. Data collection and transmission has been verified in the office environment. This proposed observational study will utilize a multidisciplinary collaboration of ZBeats Inc. (ZBTS), Stony Brook University (SBU), and Lankenau Medical Center (LMC). The study will enroll patients undergoing ECG monitoring. The primary outcome measure will be the ability to capture cardiac arrhythmias and events from participants. The prescribed FDA-cleared device will serve as the ground truth (GT) for our analyses. The detected arrhythmias and events from our solution will be compared with the findings from the ground truth to obtain our system's detection rate. The goal is to achieve a detection rate of >80% to be deemed successful.

NCT ID: NCT06001073 Not yet recruiting - Hypertension Clinical Trials

Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics

PROSPECT
Start date: December 30, 2024
Phase:
Study type: Observational

The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.

NCT ID: NCT05994755 Not yet recruiting - Heart Failure Clinical Trials

Association Between Cardiac ARRHYTHMIAs and Glycemic Variability in Patient With Type 2 Diabetes Monitored Through FREEstyle Libre and Bluetooth Technology.

ARRHYTHMIAFREE
Start date: October 30, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to investigate the association between hypoglycemia, glycemic variability and cardiac arrhythmias in patients with diabetes Type II (T2D) already implanted with implantable cardiac defibrillator (ICD) and monitored remotely through Bluetooth technology and CGM (continuous glucose monitoring).

NCT ID: NCT05983484 Completed - Cardiac Arrhythmia Clinical Trials

Holter Versus Skiin Garments

Start date: October 16, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions: - Can the textile sensors provide continuous monitoring and detect arrhythmias? - Do patients prefer to wear textile sensors instead of the Holter? Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.

NCT ID: NCT05974306 Not yet recruiting - Heart Failure Clinical Trials

Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System

VASCO
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Vasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).

NCT ID: NCT05970328 Recruiting - Clinical trials for Cardiac Rhythm Disturbance

Hexoskin Medical System - ECG Performance Testing

Start date: July 24, 2023
Phase:
Study type: Observational

The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

NCT ID: NCT05968521 Recruiting - Heart Failure Clinical Trials

Cardiac Rehabilitation for Young People

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

Heart problems are amongst the most common physical illnesses in children and young people (CYP). They can be present from birth or develop as CYP get older and are linked to increased physical and psychological difficulties overprotection from caregivers and healthcare providers and reduced quality of life. While adults are offered exercise classes and lifestyle advice after a heart problem, CYP with heart problems are not. Improving health behaviours in people with heart problems is vital, improves quality of life and reduces additional illnesses (i.e obesity, diabetes). Approximately 1 in 3 CYP with heart problems have anxiety and/or depression so it is also important to support their mental health. One way to do this is to develop and test the acceptability and feasibility of a trial of cardiac rehabilitation (CR) consisting of exercise with mental health support for CYP. The aim is to develop and test the feasibility and acceptability of a trial of a cardiac rehabilitation programme for CYP.

NCT ID: NCT05967546 Not yet recruiting - Arrhythmia Clinical Trials

Deep Learning for Intelligent Identification of Arrhythmias

ECG-LEARNING
Start date: December 30, 2024
Phase:
Study type: Observational

This study aims to design and train a deep learning model for the diagnosis of different arrhythmias.