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

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02380937
• Other study ID #: 104/14-ff
• Status: Terminated
• Phase: N/A
• First received: February 16, 2015
• Last updated: February 5, 2018
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Procedure:
• ablation for typical atrial flutter
ablation for typical atrial flutter

Device:
• Vision Ablation Catheter

Locations

Country	Name	City	State
Germany	Heart Center Leipzig	Leipzig

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	Heartcenter Leipzig GmbH, Imricor, Philips Healthcare

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Eitel C, Hindricks G, Grothoff M, Gutberlet M, Sommer P. Catheter ablation guided by real-time MRI. Curr Cardiol Rep. 2014 Aug;16(8):511. doi: 10.1007/s11886-014-0511-6. Review. — View Citation

Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using — View Citation

Piorkowski C, Grothoff M, Gaspar T, Eitel C, Sommer P, Huo Y, John S, Gutberlet M, Hindricks G. Cavotricuspid isthmus ablation guided by real-time magnetic resonance imaging. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):e7-10. doi: 10.1161/CIRCEP.112.973719. — View Citation

Sommer P, Grothoff M, Eitel C, Gaspar T, Piorkowski C, Gutberlet M, Hindricks G. Feasibility of real-time magnetic resonance imaging-guided electrophysiology studies in humans. Europace. 2013 Jan;15(1):101-8. doi: 10.1093/europace/eus230. Epub 2012 Jul 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events	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	Number of participants with successful ablation		7 days