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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT05643235 Recruiting - Atrial Fibrillation Clinical Trials

Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors

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

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

NCT ID: NCT05636956 Recruiting - Heart Failure Clinical Trials

Education and Counseling Program on Patients With CIEDs and Low HL

Start date: June 26, 2022
Phase: N/A
Study type: Interventional

The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy. The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program? Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation. Reseraches compare scores between intervention and control groups, also different times in same groups.

NCT ID: NCT05631730 Recruiting - Clinical trials for Mitral Valve Prolapse

Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

FLECAPRO
Start date: January 4, 2023
Phase: Phase 3
Study type: Interventional

FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.

NCT ID: NCT05617456 Recruiting - Atrial Fibrillation Clinical Trials

Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice

ATHENA
Start date: January 1, 2022
Phase:
Study type: Observational

ATHENA is a prospective, multicenter, non-randomized post-market study. All patients will be treated according to the standard care followed by each center. The protocol requires enrollment of consecutive patients from each center, according to eligibility criteria. During the 12 months follow-up period, clinical atrial fibrillation recurrence, occurrence of all kind of atrial arrhythmias and of all Adverse Events in the study population will be collected. The purpose of this study is to prospectively evaluate during time a large population of patients with an indication for ablation of AF, collecting data on procedural success in the acute and medium- to long-term follow-up. The primary objective of the study is the determination of up to 20 clinical and procedural parameters predicting the recurrence-free at the medium-long term follow-up in consecutive patients undergoing atrial fibrillation ablation through a standard of care pathway. The success of the ablation is defined in terms of percentage of patients free from any clinical atrial arrhythmia at a 12-month follow-up from the procedure.

NCT ID: NCT05617001 Recruiting - Arrhythmia Clinical Trials

Clinical Validation and Safety of the AC 12L ECG System Against a Standard of Care 12-Lead ECG (AC 12L ECG)

Start date: October 4, 2022
Phase: N/A
Study type: Interventional

AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed a new device: Kardia 12L to record 12-lead ECGs. However, the data generated from the new device has not yet been validated for accuracy. The specific aim of this study is to evaluate the accuracy and safety of the AC 12L ECG System. The ECGs collected by the AC 12L ECG System will be compared to simultaneous standard- of-care 12-lead ECG, recorded using the GE CardioSoft 12-lead ECG System. The ECGs will be analyzed for accuracy based on statistical difference using root-mean-square error, and cross correlation between the simultaneous 10 second recordings as well as the median beats of all 12 leads.

NCT ID: NCT05615376 Recruiting - Neoplasms Clinical Trials

Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG.

NCT ID: NCT05562804 Recruiting - Cardiac Arrhythmia Clinical Trials

Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

MVP-A&S
Start date: February 10, 2021
Phase:
Study type: Observational [Patient Registry]

Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate. The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.

NCT ID: NCT05560958 Recruiting - Cardiac Arrhythmia Clinical Trials

Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products

BIO|COLLECT-EP
Start date: January 16, 2023
Phase:
Study type: Observational [Patient Registry]

This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.

NCT ID: NCT05555849 Recruiting - Clinical trials for Arrhythmias, Cardiac

Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining

Remod
Start date: April 1, 2024
Phase:
Study type: Observational

Exercise has many well-documented effects in the prevention or treatment of disease, but recently some studies have raised awareness of the possible negative effects of too much exercise. In former elite endurance athletes, an increased risk of cardiac fibrosis and arrhythmias have been described. Whether exercise itself is the culprit remains to be explored. The right cardiac ventricle can be overloaded during long-term intense exercise, due to increased volume load and possibly an increased afterload. In a subgroub of athletes the appearance with morphological and functional changes resembling an ARVC like phenotype. Furthermore, atrial fibrillation among male middle-aged athletes is up to 5 times more common compared to age-matched non-athletes. The working hypothesis of this study is that male athletes remodel more than females and that some of thise changes are already measureable early after end of elite sporting carreer. In this prospective cohort study, of 50 elite athletes at retirement, after 3 months and thereafter yearly for five years, to determine the characteristics of remodeling of the heart focusing on the left atrial and right ventricle.

NCT ID: NCT05539040 Recruiting - Atrial Fibrillation Clinical Trials

The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

RGanglia-AF
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes. The best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people. The study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs). The study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again