386 results
The objective of the study is to demonstrate the safety and performance of the Adagio Cryoablation System in patients with paroxysmale (PAF), persistent or Long-Standing Persistent Atrial Fibrillation.
Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…
(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage mapping during sinus rhythm and pacing. (2) Establish normal values for conduction velocity during sinus rhythm of the 4 chambers. (3) Establish normal values for activation…
To demonstrate the safety, feasibility and performance of the EnSite HD Grid Catheter mapping system for advanced high-density three-dimensional mapping in patients undergoing catheter ablation procedures for the treatment of non-paroxysmal atrial…
Primary Objective: To show that an integrated chronic care program in a specialized AF clinic reduces cardiovascular hospitalizations and mortality.Secondary Objective(s): 1) To demonstrate the benefits of an integrated chronic care program in terms…
To compare acute cardiotoxicity, measured by Troponin difference pre- and post-implantation, induced by implantation and defibrillation testing of transvenous and subcutaneous ICDs.
The primary objective is to examine whether L-glutamine suppletion in patients diagnosed with AF induces HSP levels in blood samples. Furthermore, the AF incidence and burden will be derived and HSP levels will be correlated with the AF incidence…
Safety: To provide scientific evidence that use of the VAS is safe as measured by the incidence of early-onset serious adverse events (SAEs).Effectiveness: To provide scientific evidence that use of the VAS provides an effective treatment for…
The objective of the study is to evaluate the performance and efficiency of the AcQMap Imaging and Mapping System in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation
We aim to i) characterize flow patterns and ii) assess energetic properties in the LV of patients with LBBB (with and without heart failure) and iii) compare findings with those in healthy volunteers.
The primary objective is to test the hypothesis that post-MI diabetic patients with relatively preserved ejection fraction of 36-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator (S-ICD).
Primary Objective: To evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum.Secondary objective: *Localized Atrial Capture: evaluate if during the rapid pacing phase of the dual-stage…
Main objective is to compare the incidence of subclavian vein thromboses after TLE by manual traction alone versus TLE with use of the mechanical rotational dilator sheath in case of fibrous adhesions hampering extraction by manual traction alone.…
The primary objective of this study is to compare prospectively, in a randomized fashion, the sensitivity and specificity of the conventional versus a short stimulation protocol for induction of sustained monomorphic VT in patients with NICM.
Safety and electrical performance evaluation of Invicta leads moodels equipped with DF-4-connector.Clinical study to support the submission for acquiring the CE-mark.
This study aims to determine if the alert of the lay rescuers is done more efficient with the smart phone App compared to normal alert with a text-message, avoiding alarming a redundant large group of lay rescuers and if it shortens the time…
To determine the minimal amount of energy needed to effectively terminate ventricular arrhythmias
The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12…
To assess whether atrial flow patterns during sinus rhythm in patients with atrial fibrillation differ from healthy controls with sinus rhythm.
The primary aim of the present registry is to assess a risk profile including biomarkers and genetics, associated with failure of the cryoballoon AF ablation, so we can predict failure of the cryoballoon AF ablation. Failure will be assessed within…