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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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 t
Sponsor: Heartcenter Leipzig GmbH

Current Primary Outcome: Number of serious adverse events [ Time Frame: 1 day ]

To provide scientific evidence that the Vision Ablation Catheter is safe as measured by the incidence of device and procedure related serious adverse events (SAEs).


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with successful ablation [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Heartcenter Leipzig GmbH

Dates:
Date Received: February 16, 2015
Date Started: January 2015
Date Completion:
Last Updated: November 14, 2015
Last Verified: November 2015