19 results
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…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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.
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.
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…
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation (AF).
Objective of the INFINITE 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 of…
The main objective is to investigate whether and to what extent the QTc-time prolongs with the use of different types of antidepressants in adults treated with antidepressants for anxiety disorders. In addition we will investigate if there are…
Study purpose I: To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application…
The purpose of this study is to evaluate and document appropriate clinical performance of the new RELIANCE Quadripolar (4-SITE) defibrillation lead and the 4-SITE Header / Lead interface when connected to the TELIGEN 100 HE 4-SITE (VR or DR)…
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…
To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.
Objective of the study is to measure dabigatran trough levels, percentage of dabigatran glucuronidation, and diluted thrombin time, to test whether these levels are different in elderly patients.
Patients with novel onset or recurrent atrial fibrillation have an altered myocardial sympathetic activity. The quantification of sympathetic activity with 123I-mIBG scintigraphy, as well as its change over time after restoration of sinus rhythm,…
This study aims to evaluate the Corsano Cardiowatch 287-2 for heart rate, heart rate variability (RR intervals), oxygen saturation, respiratory rate, and blood pressure during strenuous activities such as High-Intensity Interval Training (HIIT).…
The main (primary) objective is to study the influence of sex on the pharmacokinetics (PK) of metoprolol in patients after CABG with heart valve surgery and patients with a STEMI/NSTEMI who are prescribed a standard dosage of metoprolol as part of…