N/A
N=50
Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
Atrial Fibrillation · Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT02467179 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Contact Force Through Measurement of Force-time Integral (FTI) — 471; 571 gm/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amigo™ Robotic Catheter Manipulation (Device); Manual Catheter Manipulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contact Force Through Measurement of Force-time Integral (FTI) |
471; 571 | — |
| SECONDARY Fluoroscopy Time Measurements |
3.8; 6.8 | — |
Summary
The purpose of this study is to compare standard manual and robotically controlled catheter ablation of the cavo-tricuspid isthmus (CTI) as a treatment for atrial flutter. Ablation of the CTI is standard treatment for patients with a history of atrial flutter, and those undergoing ablation for atrial fibrillation. Both manual and robotic catheter manipulation are used in standard clinical practice at The University of California, San Diego (UCSD) for ablation.
Eligibility Criteria
Inclusion Criteria
- Must be scheduled to undergo radiofrequency catheter ablation of the cavo-tricuspid isthmus for atrial fibrillation (AF) or atrial flutter (AFL) according to appropriate clinical indications.
- Must be able and willing to provide written informed consent
- Must be at least 18 years old.
Exclusion Criteria
- Patient's refusal to participate in the study
- Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02467179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.