COSMOS: A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter Participants with cardiac arrhythmias/ablation history who are scheduled to have a clinically-indicated catheter mapping and ablation procedure of arrhythmia management for atrial and ventricular procedures will be using multi-electrode mapping catheter. |
Device: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Pre-ablation Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter [For 1 day on the day of procedure (anytime during the study duration of 6 months)]
Number of participants with pre-ablation mapping performed successfully with the globe-shaped, high-density multi-electrode mapping catheter without resort to non-study mapping catheter will be reported. Pre-ablation mapping is considered complete when all of the following are accomplished, as applicable: 1) The entire chamber and areas associated with the targeted arrhythmia(s) are completely mapped using Fast Anatomical Mapping (FAM); 2) Substrate or previous lesion line associated with the arrhythmia(s) is mapped: a) Substrate Voltage mapping recommended for re-do Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PsAF) and Ventricular Tachycardia (VT) procedures; b) Local activation mapping recommended for complex Atrial Tachycardia (AT) and VT procedures; 3) Conduction channel, gap(s) and critical isthmus are identified (as applicable); 4) Mapping density at the areas of interests (example slow conduction zones) is adequate, as assessed by the investigator.
- Number of Participants with Clinically Indicated Mapping Performed Successfully with the Globe-Shaped, High-Density Multi-electrode Mapping Catheter Without Resort to Non-study Mapping Catheter [Up to 6 months]
Number of participants with clinically indicated mapping performed successfully with the globe-shaped, high-density multi-electrode mapping catheter without resort to non-study mapping catheter will be reported.
- Number of Participants with Serious Adverse Events (SAEs) within 7 days of Index Procedure Related to the Investigational Catheter [Up to 7 days of index procedure]
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
Secondary Outcome Measures
- Physician Assessment of Deployment, Maneuverability, and Signal Quality Acquired with the Globe-shaped, High-density Multi-electrode Mapping Catheter for Mapping in the Atria and Ventricles Using a Physician-completed Survey [Up to 6 months]
Physician assessment of deployment, maneuverability, and signal quality acquired with the globe-shaped, high-density multi-electrode mapping catheter for mapping in the atria and ventricles using a physician-completed survey will be reported. A post-procedure survey of 11 questions, each with individual sub-questions will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.
- Number of Participants with Other SAEs (Excluding Globe-shaped, High-density Multi-electrode Mapping Catheter Related SAE) within 7 days of Index Procedure [Up to 7 days of index procedure]
Number of Participants with other SAEs (excluding globe-shaped, high-density multi-electrode mapping catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. A SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-participant hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
- Number of Participants with Non-serious Adverse Events within 7 days of Index Procedure Related to the Globe-shaped, High-density Multi-electrode Mapping Catheter [Up to 7 days of index procedure]
Number of participants with non-serious adverse events within 7 days of index procedure related to the globe-shaped, high-density multi-electrode mapping catheter will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
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At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment
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Signed participants Informed Consent Form (ICF)
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Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
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Diagnosed with an arrhythmia requiring epicardial mapping
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Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
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Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm)
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Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) for participants with ventricular arrhythmia
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LVEF <= 40% for participants with atrial arrhythmia
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Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
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Contraindication to anticoagulation (that is heparin, warfarin, dabigatran)
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History of blood clotting or bleeding abnormalities (example, hypercoagulable state)
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Myocardial infarction within the past 2 months (60 days)
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Documented thromboembolic event (including Transient Ischemic Attack [TIA]) within the past 12 months (365 days)
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Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
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Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
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Participants with known untreatable allergy to contrast media
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Active illness or active systemic infection or sepsis
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Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
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Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
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Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
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Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention [PCI])
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Atrial septal closure within the past 6 weeks (42 days)
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Presence of a condition that precludes vascular access
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Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
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Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
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Concurrent enrollment in an investigational study evaluating another device or drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Onze-Lieve-Vrouw (OLV) Ziekenhuis | Aalst | Belgium | 9300 | |
| 2 | Universitair Ziekenhuis (UZ) Brussel | Brussels | Belgium | 1090 | |
| 3 | University Hospital Center Split | Split | Croatia | 21000 | |
| 4 | Ospedale Generale Regionale Francesco Miulli (F. Miulli) | Acquaviva delle fonti | Italy | 70021 |
Sponsors and Collaborators
- Biosense Webster, Inc.
Investigators
- Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Bick RL, Frenkel EP. Clinical aspects of heparin-induced thrombocytopenia and thrombosis and other side effects of heparin therapy. Clin Appl Thromb Hemost. 1999 Oct;5 Suppl 1:S7-15. Review.
- Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15.
- Calkins H, Niklason L, Sousa J, el-Atassi R, Langberg J, Morady F. Radiation exposure during radiofrequency catheter ablation of accessory atrioventricular connections. Circulation. 1991 Dec;84(6):2376-82.
- Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.
- Cox B, Durieux ME, Marcus MA. Toxicity of local anaesthetics. Best Pract Res Clin Anaesthesiol. 2003 Mar;17(1):111-36. Review.
- Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Sáenz Morales LC, Santangeli P, Sapp JL, Sarkozy A, Soejima K, Stevenson WG, Tedrow UB, Tzou WS, Varma N, Zeppenfeld K; ESC Scientific Document Group . 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Europace. 2019 Aug 1;21(8):1143-1144. doi: 10.1093/europace/euz132. Erratum in: Europace. 2019 Aug 1;21(8):1144. J Arrhythm. 2020 Jan 12;36(1):214. Europace. 2020 Mar 1;22(3):505.
- Gerstenfeld EP, Guerra P, Sparks PB, Hattori K, Lesh MD. Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. J Cardiovasc Electrophysiol. 2001 Aug;12(8):900-8.
- Gruchalla RS. 10. Drug allergy. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S548-59. Review.
- Kovoor P, Ricciardello M, Collins L, Uther JB, Ross DL. Risk to patients from radiation associated with radiofrequency ablation for supraventricular tachycardia. Circulation. 1998 Oct 13;98(15):1534-40.
- Lin, A.C. and D.J. Wilber, Complications Associated With Radiofrequency Catheter Ablation, in Radiofrequency catheter ablation of cardiac arrhythmias: basic concepts and clinical applications, S.K. Huang and D.J. Wilber, Editors. 2000, Futura: Armonk, N.Y. p. 737-746.
- Mar PL, Chong L, Perez A, Lakkireddy D, Gopinathannair R. Entrapment of diagnostic catheter within Advisor HD grid mapping catheter. J Cardiovasc Electrophysiol. 2021 Mar;32(3):860-861. doi: 10.1111/jce.14893. Epub 2021 Jan 28.
- Mertes PM, Laxenaire MC. Allergic reactions occurring during anaesthesia. Eur J Anaesthesiol. 2002 Apr;19(4):240-62. Review.
- Morcos SK, Thomsen HS, Webb JA; Contrast Media Safety Committee of the European Society of Urogenital Radiology. Prevention of generalized reactions to contrast media: a consensus report and guidelines. Eur Radiol. 2001;11(9):1720-8. Review.
- Nahass GT. Fluoroscopy and the skin: implications for radiofrequency catheter ablation. Am J Cardiol. 1995 Jul 15;76(3):174-6. Review.
- Raymond JM, Sacher F, Winslow R, Tedrow U, Stevenson WG. Catheter ablation for scar-related ventricular tachycardias. Curr Probl Cardiol. 2009 May;34(5):225-70. doi: 10.1016/j.cpcardiol.2009.01.002. Review.
- Scheinman MM, Huang S. The 1998 NASPE prospective catheter ablation registry. Pacing Clin Electrophysiol. 2000 Jun;23(6):1020-8.
- BWI_2021_01
- CIV-22-03-039047
- BWI_2021_01