MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology (MIFI)

Prospective Atrial Flutter Ablation Registry Investigating IntellaTip Mifi XP 8 mm Technology and Maximum Voltage-guided (MVG) Isthmus Ablation Approach

• Prospective Atrial Flutter Ablation Registry investigating IntellaTip Mifi XP 8 mm technology and MVG isthmus ablation approach
• Design: National, multi-centre, prospective observational registry documenting right atrial isthmus ablation
• Observational treatment: Combination of MVG ablation strategy and the IntellaTip Mifi XP 8 mm sensor technology
• Duration: Patients will be followed for 6 months post-ablation

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: Ablation of atrial flutter

Detailed Description

The MIFI Flutter Registry is a non-interventional, multi-centre, prospective registry in consecutive patients with atrial flutter and indication for right atrial isthmus ablation. The registry is an observational study and patient's participation in this study has no impact on his/her indication for treatment, diagnostics or therapy. Patients are supposed to be treated according to current guidelines and the site's internal directives.

Treatment pattern and treatment initiation, continuation or changes are solely at the discre-tion of the physician and the patient. There will be no attempt to influence the treatment patterns of any individual treating physician. All drug prescriptions will be in the usual standard of care. Participation in the registry will in no way influence payment or reimbursement for any treatment received by subjects during the study.

A minimum of 10 hospitals in Germany treating atrial flutter and using the Maximum voltage-guided (MVG) ablation technique are eligible for participation. The enrolment period is estimated to be 6 months.

Eligible are all patients with atrial flutter, who will visit consecutively a participating site of the MIFI Flutter Registry. It is planned to enrol approximately 120 patients in total.

The follow-ups of patients will be performed using a standardized patient interview (telephone call) at 6 months by Institut für Herzinfarktforschung (IHF). In case of relevant complications, the treating physician is asked to provide medical records for verification. If the patient is not accessible by phone, local registration offices will be contacted for further information.

• Study Type: Observational
• Enrollment (Actual): 121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients with acute atrial flutter (AFL) and indication for AFL ablation

Description

Inclusion Criteria:

• Atrial flutter and clinical indication for atrial flutter (AFL) ablation
• 18+ years
• Written informed consent for participation in observational study (incl. telephone follow-ups)
• Not simultaneously participating in any randomized trial
• At least one ECG-documented, symptomatic, typical atrial flut-ter episode >30sec.
• Isthmus ablation conducted in association with other ablation procedures (e.g. for atrial fibrillation) is permitted

Exclusion Criteria:

• Any prior AFL ablation
• Acute reversible causes for atrial flutter (e.g. acute myocarditis)
• Tricuspid valve replacement
• Right atrial thrombus
• Present pregnancy or breastfeeding woman
• Drug or alcohol abuse

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative time [seconds] of radiofrequency catheter ablation and energy [Joule] delivery to achieve bidirectional isthmus block	evaluate radiofrequency catheter ablation of atrial flutter, i.e. the combination of MVG ablation strategy and the IntellaTip Mifi XP 8 mm sensor technology in right atrial ablation in patients with atrial flutterbidirectional isthmus block	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Number of patients with cardiovascular and cerebrovascular events	6 months
Effectiveness	Number of patients with recurrence of atrial flutter and/or re-ablation of atrial flutter	6 months

Collaborators and Investigators

• Sponsor: Stiftung Institut fuer Herzinfarktforschung
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Thorsten Lewalter, MD, PhD, Head, Dept. of Medicine-Cardiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 16, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Ablation; Mifi technology; maximum voltage-guided ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: MIFI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to publish data in scientific journal