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

NCT ID: NCT02810938

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-08-31

Brief 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

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.

Conditions

Atrial Flutter

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Ablation of atrial flutter

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

Intervention Type: DEVICE

Other Intervention Names

Isthmus ablation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thorsten Lewalter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head, Dept. of Medicine-Cardiology and Intensive Care

Other Identifiers

MIFI

Identifier Type: -

Identifier Source: org_study_id