Track topics on Twitter Track topics that are important to you
The purpose of this clinical study is to evaluate the and performance of the Imricor Medical Systems, Inc. (Imricor) MR Ablation Catheter when used with related accessories for the treatment of type I atrial flutter. The Vision Ablation Catheter and its accessories have been designed for use under fluoroscopic or magnetic resonance guidance. The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. The study population will consist of adult patients requiring ablation for type I atrial flutter.
This is the follow-up study to NCT02699034.
The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. 35 subjects subjects meeting inclusion/exclusion criteria will participate in the study. This study requires the use of investigational products from two independent manufacturers: Imricor and Philips. Imricor has developed the ablation catheter with related accessory cables and electrophysiology (EP) recorder/stimulator system. Philips has developed an image guidance and mapping system that is compatible with the Imricor products.
The Vision-MR Ablation Catheter will be used in conjunction with the following investigational products: Advantage-MR EP Recorder/Stimulator, Vision-MR Ablation Cable Set, Vision-MR Diagnostic Cable, the interventional MRI Suite (iSuite) image guidance and mapping system, and a dStream Interface (dSIF-FE). With the exception of iSuite and dSIF-FE, which are manufactured by Philips, Imricor will provide all investigational devices used in the study.
Each procedure will require two single-use Vision-MR Ablation Catheters and one each of the two single-use accessory catheter cables.
Ablation for the treatment of arrhythmia is an inherently complex procedure. Use of the investigational products listed above under MR guidance is an emerging approach to performing the interventional electrophysiology procedure.
The study population will consist of adult patients requiring ablation for type I atrial flutter.
Study subjects will require a follow-up visit or telephone call at seven days post procedure. Accordingly, the expected total study duration is approximately 9 months with study start planned for February 2017.
This is the follow-up study to NCT02699034 which was terminated early based on a recommendation by the oversight authority. The study device (Vision-MR ablation catheter) has been improved and the EP recorder/stimulator is now CE-marked.
ablation for typical atrial flutter, catheter ablation with study device
Heart Center Leipzig
Not yet recruiting
Heartcenter Leipzig GmbH
Published on BioPortfolio: 2017-03-14T20:38:21-0400
Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablat...
The purpose of this clinical study is to evaluate the and performance of the Imricor Medical Systems, Inc. (Imricor) MR Ablation Catheter when used with related accessories for the treatme...
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the...
The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter stu...
The aim of this study was to study the risk of death and development of arrhythmia and/or subsequently heart failure after an atrial flutter ablation procedure compared with an atrial fibrillation (AF...
Catheter ablation (CA) is a well-established therapeutic option for patients with recurrent symptomatic atrial fibrillation (AF). Data on gender-related differences are limited with regard to baseline...
Catheter ablation is considered as the mainstay treatment for patients with symptomatic atrial fibrillation (AF). We aimed to determine the predictors of 30-day readmission after catheter ablation for...
The treatment effect of the hybrid procedure, consisting of a thoracoscopic ablation followed by an endocardial radiofrequency catheter ablation (RFCA), is unclear. A total of 117 ablation-naïve pati...
Today, catheter ablation is a widely used treatment for atrial fibrillation (AF) and atrial flutter (AFL). Knowledge on long-term patient-reported outcomes and readmissions is lacking and is warranted...
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
Removal of tissue by vaporization, abrasion, or destruction. Methods used include heating tissue by hot liquids or microwave thermal heating, freezing (CRYOABLATION), chemical ablation, and photoablation with LASERS.
Removal of tissue with electrical current delivered via electrodes positioned at the distal end of a catheter. Energy sources are commonly direct current (DC-shock) or alternating current at radiofrequencies (usually 750 kHz). The technique is used most often to ablate the AV junction and/or accessory pathways in order to interrupt AV conduction and produce AV block in the treatment of various tachyarrhythmias.
Impaired or delayed impulse conduction between the right and left HEART ATRIA. Advanced interatrial blocks are often associated with arrhythmias (e.g., ATRIAL FLUTTER; and ATRIAL FIBRILLATION), direct conduction block via the Bachmann's bundle and concomitant left atrial enlargement. Syndrome of advanced interatrial block associated with SUPRAVENTRICULAR TACHYCARDIA is referred to as Bayes syndrome.
Procedures used for the targeted destruction of the mucous membrane lining of the uterine cavity.
Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...