400 results
In our current study we would like to evaluate a newly developed surgical platform for minimal invasive cardiothoracic surgery: the soft tissue expander. Main objective of the study is to determine the feasibility of creating a trans tissue expander…
The primary objective is to assess the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bpm and:- an indication for…
Primary Objective: Evaluate the safety and effectiveness of FIRM-guided procedures in addition to conventional ablation for the treatment of patients with persistent atrial fibrillation (AF).Secondary Objectives:•Evaluate the acute effectiveness of…
The aim of this study is to determine if adding ablation restricted to specific areas of the left atrium to PVAI is superior to the standard care PVAI alone.
Objective of the INFINITE 2 MRI Study is to collect data on the ImageReady* MR Conditional Pacing System in subjects already implanted with the system according to standard medical guidelines for PM implantation and meets the labeled MRI Conditions…
Primary objectivesTo show that a model incorporating the novel predictors BSPM, TE-ECG and SNPs is superior to existing models in predicting maintenance of sinus rhythm after successful DCC in patients with persistent AF.Secondary objectivesTo…
Primary objectiveTo assess the outcome of NOAC associated bleeds and emergency invasive surgery or procedures. Secondary objectives1) To describe the treatment of patients presenting with NOAC associated bleeding2) To evaluate the current…
To demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than VKA therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The substudy involving…
This study will investigate the effects of renal nerve stimulation before and after percutaneous transluminal renal denervation on cardiac excitable properties including induction of ventricular tachy-arrhythmias before and after renal denervation…
Primary Objective:To demonstrate that the AlCath Flux eXtra Gold ablation catheter is non-inferior compared to historical datafrom the literature regarding the prevention of new subclinical cerebral thromboembolic lesions after PVI.Secondary…
The primary objective of this Clinical Investigation is to evaluate that micro and mini TEE can view the same required anatomical features as ICE for atrial transseptal puncture guidance.
In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.
The main objective of this study is to obtain more insight in the (human) mechanism underlying BVR by assessing the correlation between response of BVR to preload variation in study subjects (with and) without electrical remodelling (based on…
The main objective of this study is to assess whether ICD therapy in dialysis patients reduces sudden (arrhythmogenic) cardiac death. The first secondary end point is to compare total mortality death between the two groups. An other is to evaluate…
Primary Objective: to determine the prevalence of MTWA in adults with congenital heart disease who are deemed to be at high risk for ventricular arrhythmias and sudden cardiac death.Secondary Objective(s): • to describe the clinical usefulness and…
The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the…
Primary Objective: 1. To investigate the anatomical location of a TAVI-induced LBBB. Secondary Objectives: 1. To investigate during which phase of the TAVI-procedure the conduction disorder develops.2. To investigate predictors for the occurrence of…
To demonstrate that ventricular tachycardia (VT) ablation using the Niobe* ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
The primary objective of this study is to compare the effects of bucindolol and metoprolol onthe recurrence of symptomatic AF/AFL in patients with HFREF who have a *1389 arginine homozygous(*1389Arg/Arg) genotype.The secondary objectives of this…
See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…