Clinical Research Directory

StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias

This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.

Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

This study will assess the feasibility of performing pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) in patients suffering from non-traumatic out of hospital cardiac arrest (OHCA). As well as providing valuable insights into the technical feasibility of performing this procedure as part of a resuscitation attempt, the study will also document the beneficial physiological effects of REBOA in this group of patients.

Remote Patient Management of CIEDs

This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation

The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.

NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System

The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).

Modified Left Atrial Maze Procedure for Concomitant AF Ablation

Atrial fibrillation (AF) is the most common sustained arrhythmia and affects up to 60% of patients undergoing cardiac surgery. Restoring sinus rhythm improves symptoms, reduces stroke risk, and prevents heart failure. Despite guideline recommendations, surgical ablation remains underused. This study evaluates the safety and effectiveness of a standardized modified left atrial Maze procedure performed concomitantly with cardiac surgery and identifies early predictors of long-term rhythm success. The procedure consists of creating left atrial lesion sets using radiofrequency, cryothermy, or both, and systematically closing the left atrial appendage to reduce thromboembolic risk. This prospective single-center observational study includes 151 patients undergoing concomitant AF ablation. Follow-up is performed at 3, 6, and 12 months with clinical evaluation, ECG, 24-hour Holter monitoring, pacemaker interrogation when applicable, and a standardized quality-of-life questionnaire. The primary endpoint is sinus rhythm maintenance at 12 months. Secondary endpoints include operative mortality, neurological events, pacemaker implantation, reoperation for bleeding, and quality-of-life changes. The study aims to provide new insights into predictors of success and support standardized follow-up strategies for surgical AF ablation.

Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II

This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the percentage of analyzable electrocardiographic time and (3) safety by reviewing all adverse events.

Spanish Registry of Redo Procedures Following Pulmonary Vein Ablation by Pulsed Field Ablation Technology: RESET-PFA

RESET-PFA 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 kinds 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 10 clinical and procedural parameters predicting a repeat ablation procedure after the blanking period in patients that had undergone an AF ablation with pulsed field ablation through a standard of care pathway.

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

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.

Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with catheter ablation for persistent atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure.

Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital

The survival after intrahospital cardiac arrest has been reported to 15%. In Norway this varies between 16 and 23%.). Many factors are associated with survival after cardiac arrest, both intra- and prehospital. Recent studies have not included information about individual patient factors and the outcome after cardiopulmonary resuscitation (CPR). In the current hospital, we are able to record patient specific information related to a cardiac arrest/CPR situation, and thereby be able to assess patient-related factors associated with both detection, treatment and outcome of CPR.

Colchicine After Electrocardioversion for Atrial Fibrillation

The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.

Smart Textile ECG Monitoring

This research is a clinical evaluation of the Skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ECG) signals. Developed by Myant Textile Computing Inc., the Skiin chest band (i.e. as part of the Skiin Underwear family of garments) is a component of the Myant Health Platform (MHP). The MHP also consists of: (a) a mobile phone application (Skiin Connected Life Application; SCLA), and (b) the Myant Virtual Clinic Portal (MVCP). In this study, participants will wear the Skiin chest band to collect their ECG for a period of 14 days. Participants will also be provided with a smartphone that is pre-loaded with the SCLA to record any symptoms (e.g. palpitations, shortness of breath, fatigue, light- headedness, fainting, etc.) they may experience over the 14 day ECG monitoring period. The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.

Mayo AVC Registry and Biobank

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: 1. Discover new genes or altered genes (variants) which cause AVC 2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) 3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. 4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study

This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.

Cardiac Arrhythmia in Patients with End-Stage Renal Disease

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters. After the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.

Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using a Smartwatch

Implantable devices increase the detection of silent atrial fibrillation in high-risk populations, being a useful tool in the early diagnosis of these patients, allowing monitoring for a longer time. Currently, these devices can be used for monitoring and possible early diagnosis of abnormalities in order to prevent health complications and bring about better outcomes, as well as monitor the user's progress and thus prevent more serious developments. Objective: to analyze, in patients with cardiovascular disease, the electrocardiographic aspects detected from the device in comparison to the conventional electrocardiogram, identifying aspects of similarity between the tracings obtained and automatic diagnostic accuracy by the device and by the visual assessment of the tracing. Method: a cross-sectional observational study of diagnostic accuracy will be carried out at the University Hospital of the Federal University of Piaui. The following parameters were considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate of 84%, area under the receiver operating characteristic curve of 94% and an equal proportion of the number of positive and negative cases. The minimum sample size consisted of 100 patients, and an additional 10% will be added to compensate for possible losses. A total of 110 patients will be invited to participate in the study. Patients aged ≥ 18 years will be included, with the presence of one or more diagnoses below: systemic arterial hypertension, heart failure, valvular disease, coronary atherosclerotic disease, myocardial infarction, endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pace or implantable automatic defibrillator. The variables analyzed will be: clinical-demographic data of the patients, including age, sex, race, socioeconomic profile; comorbidities and electrocardiographic findings as measured by the clock and conventional ECG. The data will be analyzed comparatively between the groups: 1 = EKG on the clock; 2 = 12-lead conventional EKG and DI (single lead). The primary outcome will be the positive diagnostic correlation of the data obtained in group 1 in relation to group 2. Secondary outcomes: successful measurement of the electrocardiographic record by the clock; diagnostic accuracy of atrial fibrillation and other heart rhythm disorders.

Pattern of Cardiac Arrhythmia in Patients With MASLD

Study the relationship between patients with MASLD and cardiac arrhythmia that could be occur in thos patients

Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

SBRT in Chagas Disease Ventricular Tachycardia

This is an observational study of 10 Chagas Disease patients with Ventricular Tachycardia that have failed prior catheter ablation or have this procedure contraindicated due to clinical status. Those patients will underwent to Stereotactic Body Radiation Therapy (SBRT) targeting the area of the heart of the VT circuits. Radioablation target will be defined based on prior ablation electroanatomical mapping, VT morphology, pre-acquired imaging (CT angiogram, Cardiac Magnetic Resonance), current imaging reconstructed and integrated to electroanatomical mapping and a EP study to define current VT morphologies. Gross targeted volume (GTV), internal targeted volume (ITV) and planning targeted volume (PTV) will be defined and calculated and a single 25Gy dose will be delivered to the PTV. Patients will be followed initially for one year and efficacy endpoint will be rate of VT recurrence, time to recurrence and VT burden. Safety endpoint will be the occurrence of any adverse effect related to SBRT.

Safety and Efficacy of EasyCool Catheter

The goal of this observational study is to learn about risks and benefit of EasyCool Catheter for cardiovascular ablation in real-world patients suffering from cardiac arrythmias. The main question\[s\] it aims to answer are: * will the cardiac arrythmia be removed and remain absent oc recurrent also 3 months after procedure * what are the adverse events at procedure, after 3 and 6 months All participants will receive cardiac ablation with EasyCool catheter.

Ablation of Focal Activation in Atrial Fibrillation

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.

Repaired Tetralogy of Fallot Italian Registry

The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated. This registry will enroll prospectively patients evaluated by CMR for clinical indication in most of the CHD Italian centers. Data collection will include surgical history, clinical data, imaging data, and also adverse cardiac events for a period of 6 years.

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes