Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter
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|ClinicalTrials.gov Identifier: NCT02699034|
Recruitment Status : Terminated (Recommendation by BfArM after interim analysis)
First Posted : March 4, 2016
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Flutter||Procedure: ablation for typical atrial flutter Device: Vision-MR ablation catheter||Not Applicable|
The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. 35 subjects including 5 roll-in 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 March 2016.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter: Evaluation of a Tailored Interventional Guidance and Tracking System|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 5, 2016|
|Actual Study Completion Date :||October 5, 2016|
Experimental: ablation for typical atrial flutter
This group receives an MR-guide ablation for atrial flutter with the study device ( Vision-MR ablation catheter )
Procedure: ablation for typical atrial flutter
Device: Vision-MR ablation catheter
- Number of patients with bidirectional cavo-tricuspid isthmus block after intervention [ Time Frame: 9 months ]Acute success defined as the demonstration of the established electrophysiological endpoint (e.g. bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus) with the investigational device. Historically, the acute success rate for RF ablation of type I atrial flutter is 72%. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S achieving success, the percentage, represented as P, will be calculated as P = 100*S/N.
- Incidence of Treatment-Emergent Serious Adverse Events [Safety]) [ Time Frame: 9 months ]The primary safety endpoint is the rate of serious adverse events (SAEs) related to the device or procedure. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S experiencing an SAE related to the device or procedure, the percentage, represented as P, will be calculated as P = 100*S/N.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699034
|Heart Center Leipzig|
|Leipzig, Germany, 04289|
|Principal Investigator:||Gerhard Hindricks, MD||Heart Center Leipzig|