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

Primary Purpose

Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

OPTRELL Mapping Catheter

About this trial

This is an interventional other trial for Scar-related Atrial Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UZ Antwerpen
Virga Jessa Ziekenhuis
Vilnius University Hospital Santaros Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPTRELL Mapping Catheter

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04983797

First Posted

July 22, 2021

Last Updated

June 28, 2023

Sponsor

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04983797

Brief Title

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

Acronym

OPTIMUM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 25, 2021 (Actual)

Primary Completion Date

November 4, 2021 (Actual)

Study Completion Date

November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPTRELL Mapping Catheter

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

OPTRELL Mapping Catheter

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the OPTRELL Catheter

Description

Time Frame

Up to 7 days of index procedure at Day 0

Title

Number of Participants With Pre-ablation Mapping and Clinically Indicated Mapping Performed With the OPTRELL Catheter Without Resort to Other Mapping Catheters

Description

Number of participants with pre-ablation mapping and clinically indicated mapping performed with the OPTRELL catheter without resort to other mapping catheters were reported.

Time Frame

Up to 72 days

Secondary Outcome Measure Information:

Title

Number of Participants With SAEs Within 7 Days of Index Procedure

Description

Time Frame

Up to 7 days of index procedure at Day 0

Title

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

Description

Time Frame

Up to 7 days of index procedure at Day 0

Title

Number of Responders for Physician Assessment for Maneuverability & Handling

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Signal Collection and Quality

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Pacing

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Workflow

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Catheter Visualization

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Catheters Interactions

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Arrhythmogenicity

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Design and Coverage for Confirming PVI

Description

Time Frame

Up to 72 days

Title

Number of Responders for Physician Assessment for Ability to Characterize the Tissue

Description

Time Frame

Up to 72 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

UZ Antwerpen

City

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Virga Jessa Ziekenhuis

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Vilnius University Hospital Santaros Clinics

City

Vilnius

ZIP/Postal Code

8661

Country

Lithuania

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

http://yoda.yale.edu

Citations:

PubMed Identifier

10726030

Citation

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.

Results Reference

background

PubMed Identifier

12751552

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.

Results Reference

background

PubMed Identifier

12592301

Citation

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

Results Reference

background

PubMed Identifier

12074414

Citation

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

Results Reference

background

PubMed Identifier

11511894

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.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

10879389

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.

Results Reference

background

PubMed Identifier

33476457

Citation

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.

Results Reference

background

PubMed Identifier

29021841

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.

Results Reference

background

PubMed Identifier

19995881

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.

Results Reference

background

PubMed Identifier

11513440

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.

Results Reference

background

PubMed Identifier

9769307

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.

Results Reference

background

PubMed Identifier

7611155

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.

Results Reference

background

PubMed Identifier

1959193

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.

Results Reference

background

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

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