MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor

Status Completed

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Atrial Flutter

Clinical Trial Details

NCT number	NCT02810938
Study type	Observational [Patient Registry]
Source	Stiftung Institut fuer Herzinfarktforschung
Contact
Status	Completed
Phase
Start date	October 2016
Completion date	August 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms