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

NCT02380937 | Terminated

• 1 other identifier: 104/14-ff
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Flutter

Keywords

real-time MRI; electrophysiology study; atrial flutter; ablation; active tracking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with successful ablation

  7 days

Study Arms (1)

ablation for typical atrial flutter

EXPERIMENTAL

This group receives an MR-guide ablation for atrial flutter with the study device (catheter)

Procedure: ablation for typical atrial flutter; Device: Vision Ablation Catheter

Interventions

ablation for typical atrial flutter PROCEDURE

ablation for typical atrial flutter

ablation for typical atrial flutter

Vision Ablation Catheter DEVICE

ablation for typical atrial flutter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Leipzig: lead
• Heart Center Leipzig - University Hospital: collaborator
• Philips Healthcare: collaborator
• Imricor Medical Systems: collaborator

Study Sites (1)

Heart Center Leipzig

Leipzig, 04289, Germany

Location

Related Publications (4)

• 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.

  PMID: 22849974 BACKGROUND

• 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.

  PMID: 24952899 BACKGROUND

• 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. No abstract available.

  PMID: 23424226 BACKGROUND

• 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 a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.

  PMID: 26316146 RESULT

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerhard Hindricks, Professor

  Heart Center Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 6, 2018

Record last verified: 2015-11

Locations

DE (1)