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Radiofrequency Ablation Device
Operator guided by contact force for Atrial Flutter
N/A
Waitlist Available
Led By Paul Novak, MD
Research Sponsored by Victoria Cardiac Arrhythmia Trials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 12 weeks and 12 months post cti rfa procedure
Awards & highlights
Study 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.
Eligible Conditions
- Atrial Flutter
- Radiofrequency Catheter Ablation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ determined during rfa procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~determined during rfa procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of RFA
Secondary outcome measures
Average FTI achieved
Average FTI of segment of acute and delayed reconnection
Average axial CF achieved
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Operator guided by contact forceExperimental Treatment1 Intervention
Operator has full access to contact force parameters including force time integral (FTI).
Group II: Operator blinded to contact forceActive Control1 Intervention
Operator is blinded to contact force with ablation guided by standard markers of effective ablation.
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Who is running the clinical trial?
Victoria Cardiac Arrhythmia TrialsLead Sponsor
1 Previous Clinical Trials
73 Total Patients Enrolled
Paul Novak, MDPrincipal InvestigatorVictoria Cardiac Arrhythmia Trials
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