NCT02825498

Brief Summary

Radiofrequency ablation (RFA) is a standard treatment option for cavotricuspid isthmus (CTI) dependent atrial flutter. We plan to perform a randomized prospective trial comparing the efficacy of contact force (CF) guided CTI ablation against catheter ablation with the operator blinded to contact force parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 18, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

4.5 years

First QC Date

July 4, 2016

Last Update Submit

May 19, 2020

Conditions

Atrial FlutterRadiofrequency Catheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Efficacy of RFA

    Total RFA time required to achieve bidirectional block

    Determined during RFA procedure

Secondary Outcomes (13)

  • Recurrence of atrial flutter

    Assessed at 12 weeks and 12 months post CTI RFA procedure

  • Average total CF achieved

    Determined during RFA procedure

  • Average axial CF achieved

    Determined during RFA procedure

  • Average FTI achieved

    Determined during RFA procedure

  • Average lateral CF achieved

    Determined during RFA procedure

  • +8 more secondary outcomes

Study Arms (2)

Operator guided by contact force

EXPERIMENTAL

Operator has full access to contact force parameters including force time integral (FTI).

Device: Contact force guided RFA

Operator blinded to contact force

NO INTERVENTION

Operator is blinded to contact force with ablation guided by standard markers of effective ablation.

Interventions

Contact force guided RFADEVICE

Contact force guided RFA during Atrial Flutter ablation procedure.

Operator guided by contact force

Eligibility Criteria

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

You may qualify if:

  • Adult patients (over the age of 18) with 12 lead ECG documented paroxysmal or persistent CTI dependent atrial flutter planned to undergo CTI ablation.
  • Able and willing to give informed consent.

You may not qualify if:

  • Previous CTI ablation
  • Previous non-CTI dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Location

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Novak, MD

    Victoria Cardiac Arrhythmia Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

May 18, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations

CA(1)