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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02810938
Other study ID # MIFI
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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