Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Catheter Robotics, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Dr. Gregory Feld, M.D. is conducting a research study to find out more about the effects of using the Amigo™ Robotic System for ablation of the cavo-tricuspid isthmus (flutter isthmus) on catheter stability (stabilization of the catheter during the procedure in order to prevent movement and dislodgement) using a combination of contact force (a measurement of the force applied by the catheter tip against the tissue during the ablation procedure), location, and duration measurements during ablation of the atrial flutter circuit. Published studies have indicated that robotic catheter manipulation is safe, may reduce patient and physician x-ray exposure, and ablation procedure time. Measuring contact force has also been shown to improve both short-term and long-term procedure success. However, research on ablation of the CTI specifically, is limited. This is a randomized study comparing robotic catheter manipulation using the Amigo Robotic System to manual catheter manipulation for ablation of the CTI on measures including catheter stability, contact force, procedure time, and fluoroscopy (X-ray) time.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Catheter Manipulation | Active Comparator | 25 subjects will be randomized to this arm. Manual catheter ablation of the cavo-tricuspid isthmus will be performed. |
|
| Amigo™ Robotic Catheter Manipulation | Experimental | 25 subjects will be randomized to this arm. Robotic catheter ablation of the cavo-tricuspid isthmus with the Amigo Catheter System will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amigo™ Robotic Catheter Manipulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Force Through Measurement of Force-time Integral (FTI) | Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System | At time of the ablation procedure, which typically lasts 30-60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy Time Measurements | Determine fluoroscopy time to reach CTI block. | at time of ablation procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Feld, MD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sulpizio Cardiovascular Center | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18811813 | Result | 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. | |
| 23585253 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Contact Force Through Measurement of Force-time Integral (FTI) | Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System | Posted | Mean | Standard Deviation | gm/s | At time of the ablation procedure, which typically lasts 30-60 minutes |
|
From the time of enrollment to completion of the ablation procedure (which usually lasted 30-60 minutes).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Feld | University of California San Diego | (858) 246-2972 | gfeld@ucsd.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2015 | Jun 7, 2019 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Manual Catheter Manipulation | Device | 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. |
|
|
| 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. |
| 21091964 | Result | 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. |
| 15093885 | Result | 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. |
| 19616669 | Result | 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. |
| 24508206 | Result | 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. |
| 25465303 | Result | 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. |
| 25469738 | Result | 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. |
| 25546580 | Result | 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. |
| 25618742 | Result | 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. |
| 25687748 | Result | 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. |
| 24063921 | Result | 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. |
| 24058180 | Result | 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. |
| 24440330 | Result | 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. |
| 24800808 | Result | 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. |
| 24771262 | Result | 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. |
| 21714971 | Result | 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. |
| 29435790 | Derived | 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. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| Secondary | Fluoroscopy Time Measurements | Determine fluoroscopy time to reach CTI block. | Posted | Mean | Standard Deviation | minutes | at time of ablation procedure |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D013514 |
| Surgical Procedures, Operative |