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Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter II

NCT03078985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-02-19

No results posted yet for this study

Summary

The purpose of this clinical study is to assess the safety and performance of the Vision-MR Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse events related to the device or procedure; the primary performance endpoint will measure the acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1 atrial flutter at three months post-ablation procedure. The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. The study population will consist of adult patients requiring ablation for type I atrial flutter.

This is the follow-up study to NCT02699034.

Conditions

  • Atrial Flutter

Interventions

PROCEDURE

ablation for typical atrial flutter

Typical atrial flutter is treated by catheter ablation.

DEVICE

catheter ablation with study device

The study device is used inside the MRI environment to localize the cavotricuspid isthmus (CTI). The CTI is then treated with radiofrequency energy to achieve complete isthmus block.

Sponsors & Collaborators

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Philips Healthcare

    collaborator INDUSTRY

  • Imricor Medical System

    collaborator UNKNOWN

  • University of Leipzig

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2017-12-11
Completion
2019-01-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078985 on ClinicalTrials.gov