A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
NCT ID: NCT04983797
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2021-08-25
2021-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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OPTRELL Mapping Catheter
Participants diagnosed with cardiac arrhythmias 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 OPTRELL mapping catheter.
OPTRELL Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the management of Atrial procedure (Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation) and Ventricular procedures (Ventricular Tachycardia, Premature Ventricular Complex).
Interventions
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OPTRELL Mapping Catheter
Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the management of Atrial procedure (Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation) and Ventricular procedures (Ventricular Tachycardia, Premature Ventricular Complex).
Eligibility Criteria
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Inclusion Criteria
* At least one episode of the targeted arrhythmia (ventricular tachycardia, 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
* Signed Participant Informed Consent Form (ICF).
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria
* Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
* Atrial arrhythmias: participants with a left atrial size greater than (\>) 55 millimeters (mm)
* Left Ventricular Ejection Fraction (LVEF) less than or equal to (\<=) 25 percent (%) for Ventricular Tachycardia (VT) participants
* LVEF \<= 40% for participants with atrial arrhythmia
* Documented intracardiac thrombus as detected on imaging
* Contraindication to anticoagulation (that is heparin, warfarin, dabigatran)
* History of blood clotting or bleeding abnormalities (example hypercoagulable state)
* Myocardial infarction within the past 2 months (60 days)
* Documented thromboembolic event (including Transient Ischemic Attack \[TIA\]) within the past 12 months (365 days)
* Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
* Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
* Implanted with a prosthetic valve
* Active illness or active systemic infection or sepsis
* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* 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)
* Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention \[PCI\])
* Atrial septal closure within the past 6 weeks (42 days)
* Presence of a condition that precludes vascular access
* 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
* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
* Concurrent enrollment in an investigational study evaluating another device or drug
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Locations
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UZ Antwerpen
Antwerp, , Belgium
Virga Jessa Ziekenhuis
Hasselt, , Belgium
Vilnius University Hospital Santaros Clinics
Vilnius, , Lithuania
Countries
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References
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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. doi: 10.1177/10760296990050s103.
Cox B, Durieux ME, Marcus MA. Toxicity of local anaesthetics. Best Pract Res Clin Anaesthesiol. 2003 Mar;17(1):111-36. doi: 10.1053/bean.2003.0275.
Gruchalla RS. 10. Drug allergy. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S548-59. doi: 10.1067/mai.2003.93.
Mertes PM, Laxenaire MC. Allergic reactions occurring during anaesthesia. Eur J Anaesthesiol. 2002 Apr;19(4):240-62. doi: 10.1017/s0265021502000418.
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. doi: 10.1007/s003300000778.
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.
Scheinman MM, Huang S. The 1998 NASPE prospective catheter ablation registry. Pacing Clin Electrophysiol. 2000 Jun;23(6):1020-8. doi: 10.1111/j.1540-8159.2000.tb00891.x.
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.
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. No abstract available.
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.
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. doi: 10.1046/j.1540-8167.2001.00900.x.
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. doi: 10.1161/01.cir.98.15.1534.
Nahass GT. Fluoroscopy and the skin: implications for radiofrequency catheter ablation. Am J Cardiol. 1995 Jul 15;76(3):174-6. doi: 10.1016/s0002-9149(99)80053-8. No abstract available.
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. doi: 10.1161/01.cir.84.6.2376.
Vijgen J, Rackauskas G, Dilling-Boer D, Sarkozy A, Ciconte G, Vicedomini GG, Pappone C. Safety and feasibility of a novel multielectrode array catheter in mapping atrial and ventricular arrhythmias with high density: results from the multicenter OPTIMUM study. J Interv Card Electrophysiol. 2023 Oct;66(7):1563-1565. doi: 10.1007/s10840-023-01568-y. Epub 2023 May 25. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIV-BE-21-04-036524
Identifier Type: OTHER
Identifier Source: secondary_id
BWI_2019_02
Identifier Type: OTHER
Identifier Source: secondary_id
BWI_2019_02
Identifier Type: -
Identifier Source: org_study_id
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