8 results
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.
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…
The trial will test the hypothesis that ICD implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
Primary study objective:The primary objective of this study is to evaluate the clinical outcome of dual-chamber ICD therapy with minimized ventricular pacing compared with single-chamber device therapy with settings which are common in clinical…
The main objective of this study is to compare the occurrence of next ICD shock therapy for VT or VF in patients with hospital presentation for an ICD shock therapy for VT or VF, with a history of a myocardial infarction, between patients randomized…
The purpose of this study is to evaluate and document that the clinical performance of the TELIGEN 100 HE and COGNIS 100 HE systems and associated application software is within design specifications. It will also document the appropriate clinical…
To evaluate different cryoenergy application times using absence of DC as a surrogate for permanent PV isolation to establish optimal duration for formation of contiguous lesions and prevention of right PNP and esophageal thermal lesions during…
We hypothesize that PVAC GOLD is non-inferior to Single Tip catheter ablation with Contact Force sensor guided by 3-D mapping. This will be tested by comparing procedural characteristics and long term outcome with regard to safety, and effectiveness…