386 results
The primary objective of this study is to evaluate the adherence to a 3-month gamification intervention integrated with a recently developed platform for continuous lifestyle monitoring (Care-On) in patients with AF referred for catheter ablation.…
The purpose of the VISABL-AFL study is to demonstrate safety and efficacy of RF ablation of type I atrial flutter (AFL) with the Vision-MR Ablation Catheter 2.0 in conjunction with the Osypka HAT 500 RF generator and irrigation pump. Data collected…
In adults patients with ischemic stroke and transient ischemic attack, how often does (subclinical) AF occur?
The primary objective of this feasibility study is to demonstrate the initial safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more…
The objective of CABA-HFPEF is to assess whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular (CV) outcomes in patients with heart failure (HF) with preserved or mildly reduced ejection fraction (HFpEF or…
The overall aim of this pilot is to evaluate the technical feasibility and clinical implementation of the Stroke Box by evaluating user experience and hypertension management. The primary objective is gathering data on blood pressure management for…
We aim to assess the association between variability and irregularity in heart rate (as caused by permanent atrial fibrillation), and cognitive function. In addition, variability and irregularity of the peripheral blood pressure will be correlated…
To study the technical performance and safety of the CARTBox-CA software for identification of scar-related substrate in patients. Secondary, to explore the usability of image-guided scar-related substrate mapping using CARTBox-CA software with a…
To demonstrate the safety, performance and effectiveness of the EMPOWER* Modular Pacing System (MPS), as well as the EMPOWER and EMBLEM* Subcutaneous ICD Coordinated System. Additionally, data from this study may be used to support pre-market and…
The primary objectives of this study are to confirm the clinic al safety and effectiveness of the Aveir LP system in subjects who are indicated for VVI(R) pacemaker.
The primary objective will be evaluating the difference in detection of new AF between the intervention practices (yearly 7 days AF screening with continuous heart rhythm monitoring) and control practices (care as usual) over three years of follow-…
Primary objective: to explore the application of automatic STV measurements by the ICD (STV-ARI,automatic), by correlating the STV-ARI,automatic values to the STV-values derived from our clinical gold standard, i.e. STV-QT (STV values derived from…
Primary objective: to study in patients with heart failure and AF whether PVI or atrioventricular node ablation is non inferior with regard to all-cause mortality, cardiovascular hospitalization or changes in quality of life. Secondary objective: to…
Using state of the art CMR imaging techniques, we will characterize ablation lesions in the early phase after pulmonary vein isolation, and relate findings to (1) the ablation scar at 3 months follow up and (2) atrial fibrillation-free survival at 1…
to quantify atrial electropathology of the endocardium in adult patients with CHD and to correlate clinical characteristics, atrial volume, electropathology, atrial ectopy and features of pre- and post-procedural atrial fibrillation.
Primary Objective: • To contrast Coherent Mapping quality (electrograms per map) and noise assessment using Octaray (with TRUEREF technology) versus Pentaray catheter for left and right atrium.Secondary Objective(s): • To contrast the Coherent…
The purpose of this clinical study is to confirm safety and effectiveness of the Medtronic Evera MRI ICD in a clinical MRI environment.
The primary objective is: To obtain 256 simultaneously recorded body-surface ECGs and a torso-heart geometry (determined by CT scan) in patients, to develop and validate mathematical algorithms that can reconstruct epicardial electrical potentials.…
The primary objective is to investigate the efficacy of a magic-based intervention in alleviating short-term self-reported distress in children (7-18 years of age) undergoing catheter-based ablation for cardiac arrhythmias on the day of the…
The purpose of the VISABL-VT clinical investigation is to demonstrate safety and efficacy of RF ablation of ventricular tachycardia (VT) attributable to ischemic cardiomyopathy (ICM) with the Vision-MR Ablation Catheter 2.0. Data collected from this…