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Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter II

2017-03-14 20:38:21 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Atrial Flutter

Intervention

ablation for typical atrial flutter, catheter ablation with study device

Location

Heart Center Leipzig
Leipzig
Saxony
Germany
04289

Status

Not yet recruiting

Source

Heartcenter Leipzig GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-03-14T20:38:21-0400

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Procedures used for the targeted destruction of the mucous membrane lining of the uterine cavity.

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