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

Atrial Flutter Clinical Trial

— MIFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810938
• Other study ID #: MIFI
• Status: Completed
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety	Number of patients with cardiovascular and cerebrovascular events	6 months
Secondary	Effectiveness	Number of patients with recurrence of atrial flutter and/or re-ablation of atrial flutter	6 months