Atrial FlutterMIFINCT02810938
MIFI Flutter Registry - Ablation of Atrial Flutter With IntellaTip Sensor Technology
An observational study of Atrial Flutter, run by Stiftung Institut fuer Herzinfarktforschung.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Ablation of atrial flutter
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with acute atrial flutter (AFL) and indication for AFL ablation
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Prospective Atrial Flutter Ablation Registry Investigating IntellaTip Mifi XP 8 mm Technology and Maximum Voltage-guided (MVG) Isthmus Ablation Approach
- 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
Read the 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
- Being tested
- Ablation of atrial flutter
- Keywords
- Ablation, Mifi technology, maximum voltage-guided ablation
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation of atrial flutterDevice
Also called Isthmus ablation
Ablation of atrial flutter using IntellaTip Mifi 8 mm technology in combination with Maximum voltage-guided ablation approach
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
Safety
Number of patients with cardiovascular and cerebrovascular events
Measured: 6 months
Effectiveness
Number of patients with recurrence of atrial flutter and/or re-ablation of atrial flutter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion16 Feb 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Thorsten Lewalter, MD, PhD, Principal investigator, Head, Dept. of Medicine-Cardiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810938
- Sponsor's protocol ID
- MIFI
- Acronym
- MIFI
- Status last verified
- Sep 2019
- First submitted
- 15 Jun 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Plan to publish data in scientific journal
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Atrial Flutter Ablation Registry Investigating IntellaTip Mifi XP 8 mm Technology and Maximum Voltage-guided (MVG) Isthmus Ablation Approach
- ClinicalTrials.gov ID
- NCT02810938
- Acronym / sponsor ID
- MIFI / MIFI
- Conditions
- Atrial Flutter
- Keywords
- Ablation, Mifi technology, maximum voltage-guided ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Oct 2016 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with acute atrial flutter (AFL) and indication for AFL ablation
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation of atrial flutterAlso: Isthmus ablationAblation of atrial flutter using IntellaTip Mifi 8 mm technology in combination with Maximum voltage-guided ablation approach | Device | – |
Primary outcome
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
2 secondary outcomes
Safety
Time frame: 6 months
Effectiveness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Yes. Plan to publish data in scientific journal
Related trials for Atrial Flutter
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Lewalter, MD, PhD principal investigator
Head, Dept. of Medicine-Cardiology and Intensive Care
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Flutter, run by Stiftung Institut fuer Herzinfarktforschung.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative time [seconds] of radiofrequency catheter ablation and energy [Joule] delivery to achieve bidirectional isthmus block (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.