Evaluation of the Amigo Robotic System for Ablation of the Cavo-Tricuspid Isthmus
NCT ID: NCT02467179
Last Updated: 2019-06-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2015-03-31
2018-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Feasibility of Arrhythmia Ablation Using the Amigo Remote Robotic System as Compared With Manual Ablation
NCT01834872
Manual vs Amigo SmartTouch Atrial Fibrillation Study
NCT01583855
Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation
NCT00560872
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter
NCT05777850
Ablation Index in Standard vs. High Power Radiofrequency Ablation for Typical Atrial Flutter: A Randomized Study (AITAF)
NCT06406686
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The ablation procedure is standard of care, however, if patients chose to enroll in the study they will be randomized to one of two groups: either manual or robotic catheter manipulation. Throughout the procedure, research personnel will collect information from the procedure including measurements of contact force, catheter stability, procedure duration, and fluoroscopy (X-ray) time. If, in addition to ablation of the cavo-tricuspid isthmus for atrial flutter, a patient is scheduled to undergo ablation of the left atrium for atrial fibrillation or left atrial flutter, this will be performed subsequently in a standard manner, and will not be considered part of the research. Ablation of the CTI generally takes 45-60 minutes regardless of the technique used for manipulation of the catheters.
The patient's participation in the study will only last one day, the length of study procedure. There is no follow up associated with this study. All subjects will received standard of care treatment following their ablation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Manual Catheter Manipulation
25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed.
Manual Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
Amigo™ Robotic Catheter Manipulation
25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed.
Amigo™ Robotic Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amigo™ Robotic Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to robotic catheter manipulation.
Manual Catheter Manipulation
Ablation is a standard procedure that patients may undergo for the atrial flutter.
In this study, this group will be assigned to manual catheter manipulation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be able and willing to provide written informed consent
* Must be at least 18 years old.
Exclusion Criteria
* Lack of indication for CTI ablation (eg: prior CTI ablation with persistent bidirectional isthmus block)
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Catheter Robotics, Inc.
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gregory Kent Feld
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gregory Feld, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sulpizio Cardiovascular Center
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Shurrab M, Danon A, Lashevsky I, Kiss A, Newman D, Szili-Torok T, Crystal E. Robotically assisted ablation of atrial fibrillation: a systematic review and meta-analysis. Int J Cardiol. 2013 Nov 5;169(3):157-65. doi: 10.1016/j.ijcard.2013.08.086. Epub 2013 Sep 10.
Wood MA, Orlov M, Ramaswamy K, Haffajee C, Ellenbogen K; Stereotaxis Heart Study Investigators. Remote magnetic versus manual catheter navigation for ablation of supraventricular tachycardias: a randomized, multicenter trial. Pacing Clin Electrophysiol. 2008 Oct;31(10):1313-21. doi: 10.1111/j.1540-8159.2008.01183.x.
Proietti R, Pecoraro V, Di Biase L, Natale A, Santangeli P, Viecca M, Sagone A, Galli A, Moja L, Tagliabue L. Remote magnetic with open-irrigated catheter vs. manual navigation for ablation of atrial fibrillation: a systematic review and meta-analysis. Europace. 2013 Sep;15(9):1241-8. doi: 10.1093/europace/eut058. Epub 2013 Apr 12.
Hlivak P, Mlcochova H, Peichl P, Cihak R, Wichterle D, Kautzner J. Robotic navigation in catheter ablation for paroxysmal atrial fibrillation: midterm efficacy and predictors of postablation arrhythmia recurrences. J Cardiovasc Electrophysiol. 2011 May;22(5):534-40. doi: 10.1111/j.1540-8167.2010.01942.x. Epub 2010 Nov 23.
Feld G, Wharton M, Plumb V, Daoud E, Friehling T, Epstein L; EPT-1000 XP Cardiac Ablation System Investigators. Radiofrequency catheter ablation of type 1 atrial flutter using large-tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator: results of a multicenter safety and efficacy study. J Am Coll Cardiol. 2004 Apr 21;43(8):1466-72. doi: 10.1016/j.jacc.2003.11.036.
Sawhney N, Anousheh R, Chen WC, Narayan S, Feld GK. Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol. 2009 Aug 1;104(3):366-72. doi: 10.1016/j.amjcard.2009.03.044. Epub 2009 Jun 6.
Steinberg JS, Palekar R, Sichrovsky T, Arshad A, Preminger M, Musat D, Shaw RE, Mittal S. Very long-term outcome after initially successful catheter ablation of atrial fibrillation. Heart Rhythm. 2014 May;11(5):771-6. doi: 10.1016/j.hrthm.2014.02.003. Epub 2014 Feb 4.
Akca F, Janse P, Theuns DA, Szili-Torok T. A prospective study on safety of catheter ablation procedures: contact force guided ablation could reduce the risk of cardiac perforation. Int J Cardiol. 2015 Jan 20;179:441-8. doi: 10.1016/j.ijcard.2014.11.105. Epub 2014 Nov 13.
Sigmund E, Puererfellner H, Derndorfer M, Kollias G, Winter S, Aichinger J, Nesser HJ, Martinek M. Optimizing radiofrequency ablation of paroxysmal and persistent atrial fibrillation by direct catheter force measurement-a case-matched comparison in 198 patients. Pacing Clin Electrophysiol. 2015 Feb;38(2):201-8. doi: 10.1111/pace.12549. Epub 2014 Dec 2.
Jarman JWE, Panikker S, DAS M, Wynn GJ, Ullah W, Kontogeorgis A, Haldar SK, Patel PJ, Hussain W, Markides V, Gupta D, Schilling RJ, Wong T. Relationship between contact force sensing technology and medium-term outcome of atrial fibrillation ablation: a multicenter study of 600 patients. J Cardiovasc Electrophysiol. 2015 Apr;26(4):378-384. doi: 10.1111/jce.12606. Epub 2015 Feb 11.
le Polain de Waroux JB, Weerasooriya R, Anvardeen K, Barbraud C, Marchandise S, De Meester C, Goesaert C, Reis I, Scavee C. Low contact force and force-time integral predict early recovery and dormant conduction revealed by adenosine after pulmonary vein isolation. Europace. 2015 Jun;17(6):877-83. doi: 10.1093/europace/euu329. Epub 2015 Jan 24.
Arujuna A, Karim R, Zarinabad N, Gill J, Rhode K, Schaeffter T, Wright M, Rinaldi CA, Cooklin M, Razavi R, O'Neill MD, Gill JS. A randomized prospective mechanistic cardiac magnetic resonance study correlating catheter stability, late gadolinium enhancement and 3 year clinical outcomes in robotically assisted vs. standard catheter ablation. Europace. 2015 Aug;17(8):1241-50. doi: 10.1093/europace/euu364. Epub 2015 Feb 16.
Lopez-Gil M, Salgado R, Merino JL, Datino T, Figueroa J, Arenal A, Mejia E, Salguero R, Fontenla A, Arribas F. Cavo-tricuspid isthmus radiofrequency ablation using a novel remote navigation catheter system in patients with typical atrial flutter. Europace. 2014 Apr;16(4):558-62. doi: 10.1093/europace/eut285. Epub 2013 Sep 20.
Datino T, Arenal A, Pelliza M, Hernandez-Hernandez J, Atienza F, Gonzalez-Torrecilla E, Avila P, Bravo L, Fernandez-Aviles F. Comparison of the safety and feasibility of arrhythmia ablation using the Amigo Robotic Remote Catheter System versus manual ablation. Am J Cardiol. 2014 Mar 1;113(5):827-31. doi: 10.1016/j.amjcard.2013.11.030. Epub 2013 Dec 12.
Zhang W, Jia N, Su J, Lin J, Peng F, Niu W. The comparison between robotic and manual ablations in the treatment of atrial fibrillation: a systematic review and meta-analysis. PLoS One. 2014 May 6;9(5):e96331. doi: 10.1371/journal.pone.0096331. eCollection 2014.
Wutzler A, Wolber T, Parwani AS, Huemer M, Attanasio P, Blaschke F, Haegeli L, Haverkamp W, Duru F, Boldt LH. Robotic ablation of atrial fibrillation with a new remote catheter system. J Interv Card Electrophysiol. 2014 Sep;40(3):215-9. doi: 10.1007/s10840-014-9895-x. Epub 2014 Apr 29.
Thomas D, Scholz EP, Schweizer PA, Katus HA, Becker R. Initial experience with robotic navigation for catheter ablation of paroxysmal and persistent atrial fibrillation. J Electrocardiol. 2012 Mar;45(2):95-101. doi: 10.1016/j.jelectrocard.2011.05.005. Epub 2011 Jun 28.
Hoffmayer KS, Krainski F, Shah S, Hunter J, Alegre M, Hsu JC, Feld GK. Randomized controlled trial of Amigo(R) robotically controlled versus manually controlled ablation of the cavo-tricuspid isthmus using a contact force ablation catheter. J Interv Card Electrophysiol. 2018 Mar;51(2):125-132. doi: 10.1007/s10840-018-0319-1. Epub 2018 Feb 12.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
150318
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.