NCT02917538

Brief Summary

A clinical randomized trial to evaluate if CF guided Radio Frequency Ablation (RFA) to a specific of LSI in atrial flutter i superior to standard RFA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 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

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

November 1, 2019

Enrollment Period

2.7 years

First QC Date

September 21, 2016

Last Update Submit

September 30, 2020

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (1)

  • Rate of recurrent isthmus conduction

    Rate of recurrent isthmus conduction measured at invasive electrophysiological study 3 months after ablation

    3 months

Secondary Outcomes (13)

  • Rate of recurrent isthmus conduction in the anterior, middle or posterior third of the isthmus.

    3 months

  • Freedom from recurrence of Atrial flutter

    3 and 12 months

  • Occurrence of bidirectional isthmus block with the first ablation line.

    1 hour

  • Rate of permanent reconduction on the table

    10 minutes

  • Rate of transient reconduction on the table with adenosine

    10 minutes

  • +8 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

In the intervention group: The operator will perform the RFA treatment guided by real-time CF parameters.

Procedure: RFA

Control group

ACTIVE COMPARATOR

In the control group: The Operator will perform the RFA treatment blinded to the real-time CF parameters.

Procedure: RFA

Interventions

RFAPROCEDURE

Both groups will receive radiofrequency ablation treatment

Control groupIntervention group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with typical Atrial flutter undergoing first time Cavo Tricuspid Isthmus Ablation

You may not qualify if:

  • Congenital heart disease
  • Atrial fibrillation is the dominant arrhythmia
  • Prior right atrial atriotomy
  • Significant mitral valve disease
  • NYHA IV
  • Secondary AFL (e.g. post-surgery, infections, hyperthyroidism)
  • Age \< 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, Denmark

Location

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Cosedis Nielsen, MD, DMsci

    Aarhus University Hospital Skejby

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

May 20, 2019

Study Completion

June 1, 2020

Last Updated

October 5, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

We are not authorized to share individual participant data

Locations

DK(1)