139 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 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.
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 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
To perform a pre-study to assess the feasibility of DE-MRI to assess lesion size, transmurality and completeness of pulmonary vein isolation. The study will be performed to determine if and how DE-MRI can be used in a larger subsequent multicentre…
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…
To compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalisation, quality of Life, cost and to compare the satisfaction of the patients.
(1) to determine the feasibility to sense and pace the myocardium with an- ICD lead placed in an alternative position (2) to determine the best position for pacing and sensing in the alternative position(3) to determine the safety and feasibility to…
The objective of the present pilot study is to assess whether renal sympathetic denervation will decrease atrial fibrillation burden in patients with symptomatic paroxysmal of persistent atrial fibrillation
To perform a percutaneous renal sympathetic denervation in a cohort of 20 patients with therapy resistant CPVT and LQTS patients and to objectify and evaluate the benefit of this novel treatment for this group of patients.
To assess the prevalence of QT-prolongation in patients who are prescribed domperidone as part of usual care, and to assess potential risk factors for that QT-prolongation.
The purpose of this study is to investigate the applicability of this method of ablation in human patients.The investigation will be conducted in patients with persistent atrial fibrillation who, with use of the current method (RF-ablation), can…
The objective of the study is demonstrate the safety and efficacy of the subcutaneous defibrillation system.
PrimaryThe primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedaroSecondaryThe secondary efficacy objective is to evaluate the rate of AF…
To gather data to support global submissions/approvals for some models of the Ingenio device family.