- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05373862
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter (COSMOS)
February 13, 2024 updated by: Biosense Webster, Inc.
Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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.
Study Contact
- Name: Nathalie Macours
- Phone Number: +32 479 97 05 05
- Email: nmacours1@its.jnj.com
Study Locations
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Aalst, Belgium, 9300
- Onze-Lieve-Vrouw (OLV) Ziekenhuis
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Brussels, Belgium, 1090
- Universitair Ziekenhuis (UZ) Brussel
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Split, Croatia, 21000
- University Hospital Center Split
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Acquaviva delle fonti, Italy, 70021
- Ospedale Generale Regionale Francesco Miulli (F. Miulli)
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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, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
- At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, 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 participants 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 participants with ventricular arrhythmia
- LVEF <= 40% for participants with atrial arrhythmia
- Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
- 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)
- Participants with known untreatable allergy to contrast media
- 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 |
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Experimental: Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
Participants with cardiac arrhythmias/ablation history 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 mapping catheter.
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Participants scheduled to have a clinically-indicated catheter mapping and ablation procedure using globe-shaped, high-density, multi-electrode mapping catheter for management of atrial procedure (scar-related atrial tachycardia, persistent atrial fibrillation, paroxysmal atrial fibrillation) and Ventricular procedures (ventricular tachycardia, premature ventricular complex).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
Time Frame: Up to 7 days of index procedure on Day 1
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Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
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Up to 7 days of index procedure on Day 1
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Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
Time Frame: Up to 7 days of index procedure on Day 1
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Number of participants with SAEs within 7 days of index procedure related to the investigational 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.
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Up to 7 days of index procedure on Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Responders for Physician Assessment for Maneuverability and Handling
Time Frame: Up to 29 weeks
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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 and handling.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Signal Collection and Quality
Time Frame: Up to 29 weeks
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Number of responders for physician assessment for signal collection and quality (UNIPOLAR signals in atria/ventricles, UNIPOLAR noise encountered, BIPOLAR signals in atria/ventricles, BASELINE noise encountered, and BIPOLAR noise encountered) 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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Pacing
Time Frame: Up to 29 weeks
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Number of responders for physician assessment for pacing (high output stimulation pacing and 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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Catheter Design
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Workflow
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Catheter Visualization
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Catheters Interactions
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Arrhythmogenicity
Time Frame: Up to 29 weeks
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Number of responders for 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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Ability to Characterize the Tissue
Time Frame: Up to 29 weeks
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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.
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Up to 29 weeks
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Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly
Time Frame: Up to 29 weeks
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Number of responders for physician assessment for ability to identify arrhythmia circuit or source correctly 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 identify arrhythmia circuit or source correctly.
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Up to 29 weeks
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Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure
Time Frame: Up to 7 days of index procedure on Day 1
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Number of participants with SAEs excluding investigational catheter related 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.
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Up to 7 days of index procedure on Day 1
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Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter
Time Frame: Up to 7 days of index procedure on Day 1
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Number of participants with non-serious AEs within 7 days of index procedure related to the investigational catheter were reported.
An AE is any untoward medical occurrence in a participant whether or not related to the investigational device.
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Up to 7 days of index procedure on Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.
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.
- Raymond JM, Sacher F, Winslow R, Tedrow U, Stevenson WG. Catheter ablation for scar-related ventricular tachycardias. Curr Probl Cardiol. 2009 May;34(5):225-70. doi: 10.1016/j.cpcardiol.2009.01.002.
- 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.
- Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N, Aguinaga L, Leite LR, Al-Khatib SM, Anter E, Berruezo A, Callans DJ, Chung MK, Cuculich P, d'Avila A, Deal BJ, Della Bella P, Deneke T, Dickfeld TM, Hadid C, Haqqani HM, Kay GN, Latchamsetty R, Marchlinski F, Miller JM, Nogami A, Patel AR, Pathak RK, Saenz Morales LC, Santangeli P, Sapp JL, Sarkozy A, Soejima K, Stevenson WG, Tedrow UB, Tzou WS, Varma N, Zeppenfeld K; ESC Scientific Document Group. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Europace. 2019 Aug 1;21(8):1143-1144. doi: 10.1093/europace/euz132. Erratum In: Europace. 2019 Aug 1;21(8):1144. J Arrhythm. 2020 Jan 12;36(1):214. Europace. 2020 Mar 1;22(3):505.
- 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)
July 29, 2022
Primary Completion (Actual)
February 20, 2023
Study Completion (Actual)
February 20, 2023
Study Registration Dates
First Submitted
May 10, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 13, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BWI_2021_01 (Other Identifier: Biosense Webster, Inc.)
- CIV-22-03-039047 (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.
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