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

February 5, 2018 updated by: University of Leipzig

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First time indication for type I atrial flutter ablation
  • Age 18 or above
  • Patients willing and able (mentally and physically capable per physician's discretion) to understand the investigational nature, potential risks and benefits of the study and able to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
  • Patients able to receive anticoagulation therapy to achieve adequate anticoagulation

Exclusion Criteria:

  • Contraindication for MRI diagnostic exam
  • A cardiac ablation or cardiac surgery within 90 days prior to enrollment
  • Documented intracardiac thrombus, tumor, bleeding, clotting or other abnormality that precludes catheter introduction and placement
  • Myocardial infarction within 60 days prior to enrollment
  • Current unstable angina
  • History of cerebrovascular event (within 180 days prior to enrollment)
  • Patients with an ejection fraction less than or equal to 30% within 90 day prior to enrollment
  • Permanent leads in or through the right atrium
  • Clinically significant structural heart disease (including tricuspid valve regurgitation, tricuspid valve stenosis or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator
  • Uncompensated congestive heart failure (NYHA Class III or IV)
  • Arrhythmia is secondary to electrolyte imbalance, thyroid disease, or other
  • reversible or non-cardiovascular cause
  • Known sensitivity to heparin or warfarin
  • Active or systemic infection
  • Any other significant uncontrolled or unstable medical condition (including but not limited to hypertension and diabetes)
  • Women who are pregnant or plan to become pregnant within the course of their participation in the investigation or who are breastfeeding
  • Life expectancy of less than 12 months
  • Patients with prosthetic valves
  • Contraindicated for transfemoral venous access
  • Older than 75 years
  • Current enrollment in any other clinical investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ablation for typical atrial flutter
This group receives an MR-guide ablation for atrial flutter with the study device (catheter)
Procedure: ablation for typical atrial flutter
ablation for typical atrial flutter
Device: Vision Ablation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with successful ablation
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Philips Healthcare
Heart Center Leipzig - University Hospital
Imricor Medical Systems

Investigators

  • Principal Investigator: Gerhard Hindricks, Professor, Heart Center Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104/14-ff

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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