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

NCT04983797 | Completed Results FDA Device

• 2 other identifiers: BWI_2019_02CIV-BE-21-04-036524
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Scar-related Atrial Tachycardia; Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Premature Complexes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Number of Participants With SAEs Within 7 Days of Index Procedure

  Up to 7 days of index procedure at Day 0

• Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter

  Up to 7 days of index procedure at Day 0

• Number of Responders for Physician Assessment for Maneuverability & Handling

  Up to 72 days

• Number of Responders for Physician Assessment for Signal Collection and Quality

  Up to 72 days

• Number of Responders for Physician Assessment for Pacing

  Up to 72 days

Study Arms (1)

OPTRELL Mapping Catheter

EXPERIMENTAL

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.

Device: OPTRELL Mapping Catheter

Interventions

OPTRELL Mapping Catheter DEVICE

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).

OPTRELL Mapping Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (3)

UZ Antwerpen

Antwerp, 2650, Belgium

Location

Virga Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Vilnius University Hospital Santaros Clinics

Vilnius, 8661, Lithuania

Location

Related Publications (15)

• 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.

  PMID: 10726030 BACKGROUND

• 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.

  PMID: 12751552 BACKGROUND

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

  PMID: 12592301 BACKGROUND

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

  PMID: 12074414 BACKGROUND

• 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.

  PMID: 11511894 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10879389 BACKGROUND

• 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.

  PMID: 33476457 BACKGROUND

• 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.

  PMID: 29021841 BACKGROUND

• 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.

  PMID: 19995881 BACKGROUND

• 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.

  PMID: 11513440 BACKGROUND

• 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.

  PMID: 9769307 BACKGROUND

• 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.

  PMID: 7611155 BACKGROUND

• 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.

  PMID: 1959193 BACKGROUND

• 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.

  PMID: 37227536 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Limitations and Caveats

The study results were based on descriptive analysis for a small sample size of participants split across several arrhythmia subgroups, specifically chosen to demonstrate the performance of the catheter in both the atria and ventricles. Due to the single arm design, comparisons with the other multi-electrode mapping catheters could only be performed based on physician feedback in the post-procedure survey.

Results Point of Contact

• Title: Associate Director Medical Affairs
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 30, 2021
• Study Start: August 25, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: July 3, 2023
• Results First Posted: January 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); LI (1)