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Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter

V

Victoria Cardiac Arrhythmia Trials

Status

Unknown

Conditions

Atrial Flutter
Radiofrequency Catheter Ablation

Treatments

Device: Contact force guided RFA

Study type

Interventional

Funder types

Other

Identifiers

NCT02825498
C2016-012

Details and patient eligibility

About

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.

Full description

Subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. This will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Operator guided by contact force
Experimental group
Description:
Operator has full access to contact force parameters including force time integral (FTI).
Treatment:
Device: Contact force guided RFA
Operator blinded to contact force
No Intervention group
Description:
Operator is blinded to contact force with ablation guided by standard markers of effective ablation.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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