Clinical trial NCT02825498: Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Official title: Randomised Prospective Trial Comparing Contact Force and Non-contact Force Guided Catheter Ablation for Cavotricuspid Isthmus Dependent Atrial Flutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Flutter
Radiofrequency Catheter Ablation
Lead sponsor: Victoria Cardiac Arrhythmia Trials
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy of RFA
timeFrame: Determined during RFA procedure
Secondary outcomes:
measure: Recurrence of atrial flutter
timeFrame: Assessed at 12 weeks and 12 months post CTI RFA procedure
measure: Average total CF achieved
timeFrame: Determined during RFA procedure
measure: Average axial CF achieved
timeFrame: Determined during RFA procedure
measure: Average FTI achieved
timeFrame: Determined during RFA procedure
measure: Average lateral CF achieved
timeFrame: Determined during RFA procedure
measure: Average lesion size index (LSI) achieved
timeFrame: Determined during RFA procedure
measure: Procedural complication rate
timeFrame: Determined during RFA procedure and at 12 weeks post RFA procedure
measure: Average total CF of segment of acute and delayed reconnection
timeFrame: Determined during index and repeat RFA procedure
measure: Average lateral CF of segment of acute and delayed reconnection
timeFrame: Determined during index and repeat RFA procedure
measure: Average axial CF of segment of acute and delayed reconnection
timeFrame: Determined during index and repeat RFA procedure
measure: Average FTI of segment of acute and delayed reconnection
timeFrame: Determined during index and repeat RFA procedure
measure: Average lesion size index (LSI) of segment of acute and delayed reconnection
timeFrame: Determined during index and repeat RFA procedure
measure: Procedural efficacy of RFA
timeFrame: Determined during RFA procedure
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
Study officials:
affiliation: Victoria Cardiac Arrhythmia Trials
name: Paul Novak, MD
role: PRINCIPAL_INVESTIGATOR
References: