NCT01730807

Brief Summary

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

November 16, 2012

Last Update Submit

May 2, 2017

Conditions

Atrial Flutter

Keywords

Atrial FlutterAblationType I Atrial FlutterAtrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Acute Procedural Success

    The Demonstration of bi-directional isthmus block at the end of the ablation procedure

    one day

Secondary Outcomes (1)

  • Complication Rate at procedure

    7 days

Study Arms (1)

IntellaTip XP MiFi

EXPERIMENTAL

Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter

Device: IntellaTip MiFi XP Catheter

Interventions

IntellaTip MiFi XP CatheterDEVICE

Temperature controlled ablation catheter

IntellaTip XP MiFi

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older
  • indicated for ablation for Atrial Flutter

You may not qualify if:

  • Thrombus
  • Recent MI/cardiac revascularization
  • Prosthetic Valves
  • recent ablation for atrial flutter
  • atrial flutter with reversible cause
  • Class IV HF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5001, Australia

Location

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Prashanthan Sanders, MD

    Royal Adelaide Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 21, 2012

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

January 1, 2015

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

AU(1)