Atrial Flutter Clinical Trial
Official title:
Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter
The purpose of this clinical study is to assess the safety and performance of the Vision-MR
Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse
events related to the device or procedure; the primary performance endpoint will measure the
acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block
after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance
endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1
atrial flutter at three months post-ablation procedure. 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: 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.
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