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

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02825498
• Other study ID #: C2016-012
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 18, 2016
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Victoria Cardiac Arrhythmia Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Flutter
• Radiofrequency Catheter Ablation

Intervention

Device:
• Contact force guided RFA
Contact force guided RFA during Atrial Flutter ablation procedure.

Locations

Country	Name	City	State
Canada	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Victoria Cardiac Arrhythmia Trials

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of RFA	Total RFA time required to achieve bidirectional block	Determined during RFA procedure
Secondary	Recurrence of atrial flutter	Documented recurrence of atrial flutter	Assessed at 12 weeks and 12 months post CTI RFA procedure
Secondary	Average total CF achieved	Average total CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Secondary	Average axial CF achieved	Average axial CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Secondary	Average FTI achieved	Average FTI per ablation per segment (third) of the CTI.	Determined during RFA procedure
Secondary	Average lateral CF achieved	Average lateral CF per ablation per segment (third) of the CTI.	Determined during RFA procedure
Secondary	Average lesion size index (LSI) achieved	Average lesion size index (LSI) per ablation per segment (third) of the CTI.	Determined during RFA procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Procedural efficacy of RFA	Total procedural time required to achieve bidirectional block	Determined during RFA procedure