NCT02380937

Radio Frequency Ablation for Atrial Flutter With Magnetic Resonance Guidance and Tracking

Radio Frequency Ablation for Atrial Flutter With Magnetic Resonance Guidance and Tracking: Pilot Study Using a Combination Imricor and Philips Interventional System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Radio Frequency Ablation for Atrial Flutter with Magnetic Resonance Guidance and Tracking Pilot Study (hereafter referred to as "pilot study") is a prospective, non- randomized, single-center, pilot study. The purpose of this clinical study is to evaluate the safety and performance of the Imricor Medical Systems, Inc. (Imricor) Vision 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.

Detailed description

An objective of the study is to perform the entire ablation procedure from subject preparation through confirmation of bidirectional conduction block entirely under magnetic resonance guidance. However, at the investigator's discretion, the preparation of the subject may occur in a conventional electrophysiology laboratory followed by transferring the patient to the magnetic resonance suite for the ablation procedure. Additionally, if bidirectional conduction block is not achieved within 90 minutes from the initial catheter placement, the subject may be transferred from the magnetic resonance suite to a conventional electrophysiology lab to complete the procedure. Clinical success is bidirectional conduction block regardless of the environment within which the ablation occurs. The study will be conducted at a single center, Herzzentrum Leipzig University Hospital, in Germany, and a maximum of 30 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 accessories, introducers, and recording system. Philips has developed an image guidance and mapping system that is compatible with the Imricor products. The Vision Ablation Catheter will be used in conjunction with the following investigational products: Vision Ablation Catheter Cable Set (accessory sterile cable), Vision Hemostasis Introducer, Vision Dual-Deflect Sheath, Horizon recording system, and the interventional MRI Suite (iSuite) image guidance and mapping system. With the exception of iSuite, which is manufactured by Philips, Imricor will provide all investigational devices used in the study. Each procedure will utilize the following two single-use products: two Vision Ablation Catheters and an accessory Catheter Cable set. At the discretion of the investigator, Vision Hemostasis Introducers may be used for femoral access and a Vision Dual- Deflect Sheath and may be used in conjunction with the Vision Ablation Catheter Cable Set. Ablation for the treatment of arrhythmia is an inherently complex procedure. Use of the investigational products listed above under magnetic resonance guidance is a new 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 7 days post procedure. Accordingly, the expected total study duration is approximately six months with study start planned for October 2014.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
PROCEDURE	ablation for typical atrial flutter	ablation for typical atrial flutter
DEVICE	Vision Ablation Catheter

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-03-05
• Last updated: 2018-02-06

Locations

1 site across 1 country: Germany