A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter

Paroxysmal Atrial Fibrillation Clinical Trial

— OPTIMUM  

Official title:

Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983797
• Other study ID #: BWI_2019_02
• Secondary ID: CIV-BE-21-04-036
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: November 4, 2021

Study information

• Verified date: June 2023
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the performance and safety for the use of the OPTRELL Catheter for intracardiac mapping in the atria and ventricles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included)

• 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:

• Diagnosed with an arrhythmia requiring epicardial mapping

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Antwerpen
Belgium	Virga Jessa Ziekenhuis	Hasselt
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Belgium,  Lithuania, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gruchalla RS. 10. Drug allergy. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S548-59. doi: 10.1067/mai.2003.93. — View Citation

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. — View Citation

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. — View Citation

Mertes PM, Laxenaire MC. Allergic reactions occurring during anaesthesia. Eur J Anaesthesiol. 2002 Apr;19(4):240-62. doi: 10.1017/s0265021502000418. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter	Number of participants with SAEs within 7 days of index procedure related to the OPTRELL catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	Up to 7 days of index procedure at Day 0
Primary	Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters	Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.	Up to 72 days
Secondary	Number of Participants With SAEs Within 7 Days of Index Procedure	Number of participants with SAEs within 7 days of index procedure were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	Up to 7 days of index procedure at Day 0
Secondary	Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter	Number of participants with non-serious adverse events within 7 days of index procedure associated with the use of the OPTRELL catheter were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 7 days of index procedure at Day 0
Secondary	Number of Responders for Physician Assessment for Maneuverability & Handling	Number of responders for physician assessment for maneuverability & handling were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for maneuverability & handling.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Signal Collection and Quality	Number of responders for physician assessment for signal collection and quality were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for signal collection and quality	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Pacing	Number of responders for physician assessment for pacing (local pacing capture) were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for pacing.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping	Number of responders for physician assessment for catheter design were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter design in OPTRELL catheter for mapping.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Workflow	Number of responders for physician assessment for workflow were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for workflow.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Catheter Visualization	Number of responders for physician assessment for catheter visualization were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheter visualization.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Catheters Interactions	Number of responders for physician assessment for catheters interactions were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for catheters interactions.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Arrhythmogenicity	Number of responders with physician assessment for arrhythmogenicity were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for arrhythmogenicity.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI	Number of responders for physician assessment for design and coverage for confirming PVI were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for design and coverage for confirming PVI.	Up to 72 days
Secondary	Number of Responders for Physician Assessment for Ability to Characterize the Tissue	Number of responders for physician assessment for ability to characterize the tissue were reported. A post-procedure survey of 11 questions, each with individual sub-questions were asked. Each question/sub-question was answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent). Responders refers to participants with physician assessment for ability to characterize the tissue.	Up to 72 days