MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology (MIFI)
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|ClinicalTrials.gov Identifier: NCT02810938|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : October 1, 2019
- 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
|Condition or disease||Intervention/treatment|
|Atrial Flutter||Device: Ablation of atrial flutter|
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 [Patient Registry]|
|Actual Enrollment :||121 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Prospective Atrial Flutter Ablation Registry Investigating IntellaTip Mifi XP 8 mm Technology and Maximum Voltage-guided (MVG) Isthmus Ablation Approach|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 16, 2018|
|Actual Study Completion Date :||August 2018|
- Device: Ablation of atrial flutter
Ablation of atrial flutter using IntellaTip Mifi 8 mm technology in combination with Maximum voltage-guided ablation approachOther Name: Isthmus ablation
- Cumulative time [seconds] of radiofrequency catheter ablation and energy [Joule] delivery to achieve bidirectional isthmus block [ Time Frame: 1 day ]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
- Safety [ Time Frame: 6 months ]Number of patients with cardiovascular and cerebrovascular events
- Effectiveness [ Time Frame: 6 months ]Number of patients with recurrence of atrial flutter and/or re-ablation of atrial flutter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810938
|Principal Investigator:||Thorsten Lewalter, MD, PhD||Head, Dept. of Medicine-Cardiology and Intensive Care|