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

Victoria Cardiac Arrhythmia Trials100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Atrial Flutter Radiofrequency Catheter Ablation

Interventions

Contact force guided RFADEVICE

Contact force guided RFA during Atrial Flutter ablation procedure.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Outcomes

Primary Outcomes

Efficacy of RFA

Total RFA time required to achieve bidirectional block

Time frame: Determined during RFA procedure

Secondary Outcomes

Recurrence of atrial flutter

Documented recurrence of atrial flutter

Time frame: Assessed at 12 weeks and 12 months post CTI RFA procedure

Average total CF achieved

Average total CF per ablation per segment (third) of the CTI.

Time frame: Determined during RFA procedure

Average axial CF achieved

Average axial CF per ablation per segment (third) of the CTI.

Time frame: Determined during RFA procedure

Average FTI achieved

Average FTI per ablation per segment (third) of the CTI.

Time frame: Determined during RFA procedure

Average lateral CF achieved

Average lateral CF per ablation per segment (third) of the CTI.

Time frame: Determined during RFA procedure

Average lesion size index (LSI) achieved

Average lesion size index (LSI) per ablation per segment (third) of the CTI.

Time frame: Determined during RFA procedure

Procedural complication rate

Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding.

Time frame: Determined during RFA procedure and at 12 weeks post RFA procedure

Data from ClinicalTrials.gov

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