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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operator guided by contact force | Experimental | Operator has full access to contact force parameters including force time integral (FTI). |
|
| Operator blinded to contact force | No Intervention | Operator is blinded to contact force with ablation guided by standard markers of effective ablation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact force guided RFA | Device | Contact force guided RFA during Atrial Flutter ablation procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of RFA | Total RFA time required to achieve bidirectional block | Determined during RFA procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial flutter | Documented recurrence of atrial flutter | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Novak, MD | Victoria Cardiac Arrhythmia Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Cardiac Arrhythmia Trials | Victoria | British Columbia | Canada |
De-identified IPD may be shared with other researchers upon study completion. Data may be obtained by contacting Victoria Cardiac Arrhythmia Trials Inc. at 250-595-0400.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 3, 2023 | |
| Reset | Jan 10, 2024 | |
| Release | Apr 22, 2024 |
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| Determined during RFA procedure |
| Average axial CF achieved | Average axial CF per ablation per segment (third) of the CTI. | Determined during RFA procedure |
| Average FTI achieved | Average FTI per ablation per segment (third) of the CTI. | Determined during RFA procedure |
| Average lateral CF achieved | Average lateral CF per ablation per segment (third) of the CTI. | Determined during RFA procedure |
| Average lesion size index (LSI) achieved | Average lesion size index (LSI) per ablation per segment (third) of the CTI. | Determined during RFA procedure |
| Procedural complication rate | Incidence of procedural complications: stroke, cardiac perforation, steam pops, access site bleeding. | Determined during RFA procedure and at 12 weeks post RFA procedure |
| Average total CF of segment of acute and delayed reconnection | Average total CF per ablation in segment (third) of acute or delayed reconnection. | Determined during index and repeat RFA procedure |
| Average lateral CF of segment of acute and delayed reconnection | Average lateral CF per ablation in segment (third) of acute or delayed reconnection. | Determined during index and repeat RFA procedure |
| Average axial CF of segment of acute and delayed reconnection | Average axial CF per ablation in segment (third) of acute or delayed reconnection. | Determined during index and repeat RFA procedure |
| Average FTI of segment of acute and delayed reconnection | Average FTI per ablation in segment (third) of acute or delayed reconnection. | Determined during index and repeat RFA procedure |
| Average lesion size index (LSI) of segment of acute and delayed reconnection | Average lesion size index (LSI) per ablation in segment (third) of acute or delayed reconnection. | Determined during index and repeat RFA procedure |
| Procedural efficacy of RFA | Total procedural time required to achieve bidirectional block | Determined during RFA procedure |
| Reset | Sep 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 3, 2023 | Jan 10, 2024 | |||
| Apr 22, 2024 | Sep 12, 2024 |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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