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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Atrial Flutter

Intervention / Treatment
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* Device: Ablation of atrial flutter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ablation of atrial flutter|Ablation of atrial flutter using IntellaTip Mifi 8 mm technology in combination with Maximum voltage-guided ablation approach|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ablation, Mifi technology, maximum voltage-guided ablation