Atrial Flutter, Radiofrequency Catheter Ablation
Conditions
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.
Interventions
DEVICEContact force guided RFA
Contact force guided RFA during Atrial Flutter ablation procedure.
Sponsors
Victoria Cardiac Arrhythmia Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of RFA | Determined during RFA procedure | Total RFA time required to achieve bidirectional block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average total CF achieved | Determined during RFA procedure | Average total CF per ablation per segment (third) of the CTI. |
| Average axial CF achieved | Determined during RFA procedure | Average axial CF per ablation per segment (third) of the CTI. |
| Average FTI achieved | Determined during RFA procedure | Average FTI per ablation per segment (third) of the CTI. |
| Average lateral CF achieved | Determined during RFA procedure | Average lateral CF per ablation per segment (third) of the CTI. |
| Average lesion size index (LSI) achieved | Determined during RFA procedure | Average lesion size index (LSI) per ablation per segment (third) of the CTI. |
| Procedural complication rate | Determined during RFA procedure and at 12 weeks post RFA procedure | Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding. |
| Recurrence of atrial flutter | Assessed at 12 weeks and 12 months post CTI RFA procedure | Documented recurrence of atrial flutter |
| Average lateral CF of segment of acute and delayed reconnection | Determined during index and repeat RFA procedure | Average lateral CF per ablation in segment (third) of acute or delayed reconnection. |
| Average axial CF of segment of acute and delayed reconnection | Determined during index and repeat RFA procedure | Average axial CF per ablation in segment (third) of acute or delayed reconnection. |
| Average FTI of segment of acute and delayed reconnection | Determined during index and repeat RFA procedure | Average FTI per ablation in segment (third) of acute or delayed reconnection. |
| Average lesion size index (LSI) of segment of acute and delayed reconnection | Determined during index and repeat RFA procedure | Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection. |
| Procedural efficacy of RFA | Determined during RFA procedure | Total procedural time required to achieve bidirectional block |
| Average total CF of segment of acute and delayed reconnection | Determined during index and repeat RFA procedure | Average total CF per ablation in segment (third) of acute or delayed reconnection. |
Countries
Canada
Outcome results
None listed