195 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…
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…
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.
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…
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 (…
The primary objective of the study is to outline the advantages of LP implantation in TAVI patients who require temporary, and possibly permanent pacing compared to the Standard of Care using TV-TP therapy. We will study whether placement of a LP…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
To determine the lowest energy which successfully converts induced ventricular arrhythmias in S-ICD patients.
The primary purpose is to assess the defibrillation efficacy of Medtronic subcutaneous defibrillation system.
To evaluate the safety and performance of the BackBeat Moderato system.
Primary objectives: To find out whether catheter ablation in the very early stages of AF ( i.e. no structural nor electrical remodeling) compared to AADs leads to 1) more effective rhythm control after a blanking period of three months during an…
The purpose of the study is to demonstrate that in patients of 65 years or older with symptomatic paroxysmal atrial fibrillation (AF) pulmonary vein isolation (PVI) using RF ablation therapy is superior to medical treatment with amiodarone to…
Primary objective:• To investigate whether Enhanced programming is safe for primary and secondary prevention patientsSecondary objectives:• Investigate the impact of Enhanced programming on adverse events (related to ICD shock with consequences and…
The purpose of this clinical study is to evaluate asymptomatic cerebral embolic (ACE) in subjects with symptomatic paroxysmal atrial fibrillation (AF) undergoing ablation with the Pulmonary Vein Ablation CAtheter GOLD (PVAC GOLD).(See also p. 13 of…
The aim of this pilotstudy is to obtain data regarding feasibility, safety and costs of home-based electrical cardioversion
Demonstrate that the observed incidence of procedure and/or device related incidence of new stroke (excludes transient ischemic attack) within 30 days of an ablation procedure (index or reablation) with the Phased RF System is less than 1.8% with…