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Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter

Primary Purpose

Atrial Flutter

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

ablation for typical atrial flutter

Vision-MR ablation catheter

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring real-time MRI, electrophysiology study, atrial flutter ablation, active tracking

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Heart Center Leipzig

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ablation for typical atrial flutter

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02699034

First Posted

February 19, 2016

Last Updated

February 5, 2018

Sponsor

University of Leipzig

Collaborators

Heart Center Leipzig - University Hospital, Philips Healthcare, Imricor Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT02699034

Brief Title

Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter

Official Title

Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter: Evaluation of a Tailored Interventional Guidance and Tracking System

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Terminated

Why Stopped

Recommendation by BfArM after interim analysis

Study Start Date

March 2016 (undefined)

Primary Completion Date

June 5, 2016 (Actual)

Study Completion Date

October 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Leipzig

Collaborators

Heart Center Leipzig - University Hospital, Philips Healthcare, Imricor Medical Systems

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. 35 subjects including 5 roll-in 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 accessory cables and electrophysiology (EP) recorder/stimulator system. Philips has developed an image guidance and mapping system that is compatible with the Imricor products. The Vision-MR Ablation Catheter will be used in conjunction with the following investigational products: Advantage-MR EP Recorder/Stimulator, Vision-MR Ablation Cable Set, Vision-MR Diagnostic Cable, the interventional MRI Suite (iSuite) image guidance and mapping system, and a dStream Interface (dSIF-FE). With the exception of iSuite and dSIF-FE, which are manufactured by Philips, Imricor will provide all investigational devices used in the study. Each procedure will require two single-use Vision-MR Ablation Catheters and one each of the two single-use accessory catheter cables. Ablation for the treatment of arrhythmia is an inherently complex procedure. Use of the investigational products listed above under MR guidance is an emerging 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 seven days post procedure. Accordingly, the expected total study duration is approximately 9 months with study start planned for March 2016.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Flutter

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ablation for typical atrial flutter

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

ablation for typical atrial flutter

Intervention Type

Device

Intervention Name(s)

Vision-MR ablation catheter

Primary Outcome Measure Information:

Title

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

Description

Time Frame

9 months

Title

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

Description

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Hindricks, MD

Organizational Affiliation

Heart Center Leipzig

Official's Role

Principal Investigator

Facility Information:

Facility Name

Heart Center Leipzig

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26316146

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 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.

Results Reference

background

Links:

URL

http://www.imricor.com

Description

Imricor website

Learn more about this trial

Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter

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