NCT02810938

Completed

MIFI Flutter Registry - Ablation of Atrial Flutter With Inte...

Stiftung Institut fuer Herzinfarktforschung Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

MIFI

Study Type

observational

Actual enrollment (reported)

121

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2016

Actual (reported)

Primary Completion

February 16, 2018

Actual (reported)

Study Completion

August 2018

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 121 participants
Study completion date: August 2018
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 15, 2016
Actual (reported)
First Posted
June 23, 2016
Actual (reported)
Study Start
October 2016
Actual (reported)
Primary Completion
February 16, 2018
Actual (reported)
Study Completion
August 2018
Actual (reported)

Last Updated: October 1, 2019
Status Verified: September 2019
Last Update Submitted: September 27, 2019

Conditions

Atrial Flutter

Keywords

AblationMifi technologymaximum voltage-guided ablation

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Safety
6 months
Effectiveness
6 months

Interventions

Ablation of atrial flutterDevice

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

Also known as: Isthmus ablation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Consecutive patients with acute atrial flutter (AFL) and indication for AFL ablation

You may qualify if:

Atrial flutter and clinical indication for atrial flutter (AFL) ablation

Sponsors & Collaborators

Stiftung Institut fuer Herzinfarktforschung
Otherlead
Boston Scientific Corporation
Industrycollaborator

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Thorsten Lewalter, MD, PhD
Head, Dept. of Medicine-Cardiology and Intensive Care
PRINCIPAL INVESTIGATOR

Enrollment

121 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Target Duration: 6 Months
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 23, 2016

Study Start

October 2016

Actual (reported)

NCT02699034

Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter

Not ApplicableTerminated

NCT02591875

Atrial Flutter Ablation in a Real World Population

Unknown

NCT04001530

Half-normal Saline in Atrial Flutter Ablation

Not ApplicableCompleted

NCT02380937

Radio Frequency Ablation for Atrial Flutter With Magnetic Resonance Guidance and Tracking

Not ApplicableTerminated

NCT02426710

Intracardiac Echocardiography in Atrial Flutter Ablation

Phase 3Completed

NCT02490033

The VERISMART Trial

Not ApplicableCompleted

+ 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

February 16, 2018

Actual (reported)

Study Completion

August 2018

Actual (reported)

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02810938
Data provider: ClinicalTrials.gov
Source updated: 2019-10-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:44 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record