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

NCT02810938 | Completed DMC

• 1 other identifier: MIFI
• Study Type: observational
• Target: 121
• Locations: 0 countries
• Sites: N/A

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

Conditions

Atrial Flutter

Keywords

Ablation; Mifi technology; maximum 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 flutter DEVICE

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

Also known as: Isthmus ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability 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
• + 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

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorsten Lewalter, MD, PhD

  Head, Dept. of Medicine-Cardiology and Intensive Care

  PRINCIPAL INVESTIGATOR

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 1, 2016
• Primary Completion: February 16, 2018
• Study Completion: August 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share