Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter

NCT02699034 | Terminated

• 1 other identifier: 2015-IMR
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the and performance of the Imricor Medical Systems, Inc. (Imricor) MR 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. The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. The study population will consist of adult patients requiring ablation for type I atrial flutter.

Conditions

Atrial Flutter

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of patients with bidirectional cavo-tricuspid isthmus block after intervention

  Acute success defined as the demonstration of the established electrophysiological endpoint (e.g. bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus) with the investigational device. Historically, the acute success rate for RF ablation of type I atrial flutter is 72%. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S achieving success, the percentage, represented as P, will be calculated as P = 100\*S/N.

  9 months

• Incidence of Treatment-Emergent Serious Adverse Events [Safety])

  The primary safety endpoint is the rate of serious adverse events (SAEs) related to the device or procedure. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S experiencing an SAE related to the device or procedure, the percentage, represented as P, will be calculated as P = 100\*S/N.

  9 months

Study Arms (1)

ablation for typical atrial flutter

EXPERIMENTAL

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

Procedure: ablation for typical atrial flutter; Device: Vision-MR ablation catheter

Interventions

ablation for typical atrial flutter PROCEDURE

ablation for typical atrial flutter

Vision-MR 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 ablation for type I atrial flutter.
• 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 180 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 35% 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)
• contraindication for conventional ablation procedure know allergy against radiocontrast agents renal insufficiency with glomerular filtration rate \< 30ml/min/1,73m2

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 (1)

• 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 BACKGROUND

Related Links

• Imricor website

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, MD

  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 19, 2016
• First Posted: March 4, 2016
• Study Start: March 1, 2016
• Primary Completion: June 5, 2016
• Study Completion: October 5, 2016
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)