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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810938
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung

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

Condition or disease Intervention/treatment
Atrial Flutter Device: Ablation of atrial flutter

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 121 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]
    Number of patients with cardiovascular and cerebrovascular events

  2. Effectiveness [ Time Frame: 6 months ]
    Number of patients with recurrence of atrial flutter and/or re-ablation of atrial flutter



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive patients with acute atrial flutter (AFL) and indication for AFL ablation
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Boston Scientific Corporation
Investigators
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Principal Investigator: Thorsten Lewalter, MD, PhD Head, Dept. of Medicine-Cardiology and Intensive Care
Additional Information:

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Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02810938    
Other Study ID Numbers: MIFI
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to publish data in scientific journal
Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Ablation
Mifi technology
maximum voltage-guided ablation
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes