- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983797
A Study Assessing Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter (OPTIMUM)
June 28, 2023 updated by: Biosense Webster, Inc.
Clinical Evaluation of Arrhythmia Mapping With the Multi-Electrode OPTRELL™ Mapping Catheter
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter
Time Frame: Up to 7 days of index procedure at Day 0
|
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
Time Frame: Up to 72 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With SAEs Within 7 Days of Index Procedure
Time Frame: Up to 7 days of index procedure at Day 0
|
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
|
Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Associated With the Use of the OPTRELL Catheter
Time Frame: 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 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
|
Number of Responders for Physician Assessment for Maneuverability & Handling
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Signal Collection and Quality
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Pacing
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Workflow
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Catheter Visualization
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Catheters Interactions
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Arrhythmogenicity
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI
Time Frame: Up to 72 days
|
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
|
Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Time Frame: Up to 72 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2021
Primary Completion (Actual)
November 4, 2021
Study Completion (Actual)
November 4, 2021
Study Registration Dates
First Submitted
July 22, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BWI_2019_02 (Other Identifier: Biosense Webster, Inc.)
- CIV-BE-21-04-036524 (Other Identifier: EUDAMED CIV-ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health.
Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tachycardia, Ventricular
-
University of PretoriaCompletedSupra-ventricular TachycardiaSouth Africa
-
Ottawa Heart Institute Research CorporationNot yet recruitingVentricular Fibrillation | Ventricular Tachycardia | Ventricular Arrhythmias | Recurrent Ventricular Tachycardia
-
Armgo Pharma, Inc.Food and Drug Administration (FDA)RecruitingCatecholaminergic Polymorphic Ventricular Tachycardia Type 1United States, Netherlands
-
University of Turin, ItalyAzienda Unità Sanitaria Locale Reggio Emilia; IRCCS Sacro Cuore Don Calabria... and other collaboratorsRecruitingRefractory Ventricular TachycardiaItaly
-
Thermedical, Inc.Not yet recruitingRefractory Ventricular TachycardiaUnited States, Canada
-
John SappCompleted
-
University of California, Los AngelesCompletedRefractory Ventricular TachycardiaUnited States
-
Hospital General Universitario Gregorio MarañonCompletedMonomorphic Ventricular TachycardiaSpain
-
Abbott Medical DevicesTerminatedMonomorphic Ventricular TachycardiaUnited States, United Kingdom, France, Australia, Italy
-
Abbott Medical DevicesWithdrawn
Clinical Trials on OPTRELL Mapping Catheter
-
Boston Scientific CorporationCompletedCardiac ArrhythmiasUnited States, Netherlands, Hong Kong, France, Spain, Germany, Australia, United Kingdom
-
Klinikum-FuerthUniversity of Trieste; Boston Scientific CorporationRecruitingRadiation Exposure | Catheter Ablation | Atrial Flutter TypicalGermany
-
University Hospital, Basel, SwitzerlandBoston Scientific CorporationCompleted
-
Boston Scientific CorporationCompleted
-
afreeze GmbHCompetence Center for Medical Devices GmbHRecruitingHeart Diseases | Cardiovascular Diseases | Atrial Fibrillation | Arrhythmias, Cardiac | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationAustria, Germany
-
Liverpool Heart and Chest Hospital NHS Foundation...Newcastle-upon-Tyne Hospitals NHS Trust; Imperial College Healthcare NHS TrustNot yet recruiting
-
Angelo BivianoCompleted
-
University of PittsburghMedtronicCompleted
-
Abbott Medical DevicesCompletedVentricular Tachycardia | Persistent Atrial FibrillationCanada, South Africa, Denmark, Australia, Italy, Austria, France, Germany, Netherlands, Portugal, Spain
-
Abbott Medical DevicesCompletedNon-paroxysmal Atrial Fibrillation | Left Atrial TachycardiaHong Kong, Australia, Italy, Germany, France