Who is sponsoring NCT04983797?

NCT04983797 is sponsored by Biosense Webster, Inc..

What drugs are being tested in NCT04983797?

Interventions in NCT04983797: OPTRELL Mapping Catheter.

What condition does NCT04983797 study?

NCT04983797 studies Scar-related Atrial Tachycardia, Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Premature Complexes.

Is NCT04983797 still recruiting?

NCT04983797 is currently completed. Last updated 3 July 2023.

Are results published for NCT04983797?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-03 · How we verify

NCT04983797: OPTIMUM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 3 July 2023

What this trial tests

NA trial testing OPTRELL Mapping Catheter in Scar-related Atrial Tachycardia in 31 participants. Completed in 4 November 2021.

Timeline

25 August 2021

Primary endpoint
4 November 2021

4 November 2021

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	31
Start date	25 August 2021
Primary completion	4 November 2021
Estimated completion	4 November 2021
Sites	3 locations across Belgium, Lithuania

Drugs / interventions tested

OPTRELL Mapping Catheter

Conditions studied

Scar-related Atrial Tachycardia — all drugs for Scar-related Atrial Tachycardia →
Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
Tachycardia, Ventricular — all drugs for Tachycardia, Ventricular →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with Scar-related Atrial Tachycardia or Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
OPTRELL Mapping Catheter	0

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

Group	Value	95% CI
OPTRELL Mapping Catheter	31

Number of Participants With SAEs Within 7 Days of Index Procedure Secondary · 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.

Group	Value	95% CI
OPTRELL Mapping Catheter	3

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

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Maneuverability & Handling Secondary · 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.

Ability to Deploy (Left Atrium): Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to Deploy (Left Atrium): Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to Deploy (Left Atrium): Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to Deploy (Left Atrium): Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to Deploy (Left Atrium): Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to Deploy (Left Atrium): Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	6

Ability to Deploy (Left Atrium): Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	17

Ability to Deploy (Right Atrium): Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Signal Collection and Quality Secondary · 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

UNIPOLAR signals in Atrium: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

UNIPOLAR signals in Atrium: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

UNIPOLAR signals in Atrium: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

UNIPOLAR signals in Atrium: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	0

UNIPOLAR signals in Atrium: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	1

UNIPOLAR signals in Atrium: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	4

UNIPOLAR signals in Atrium: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	2

UNIPOLAR signals in Ventricle: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Pacing Secondary · 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.

Local pacing capture: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Local pacing capture: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Local pacing capture: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	1

Local pacing capture: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	1

Local pacing capture: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	2

Local pacing capture: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	2

Local pacing capture: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	3

Number of Responders for Physician Assessment for Catheter Design in OPTRELL Catheter for Mapping Secondary · 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.

Ability to achieve electrode contact with cardiac tissue: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to achieve electrode contact with cardiac tissue: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	1

Ability to achieve electrode contact with cardiac tissue: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to achieve electrode contact with cardiac tissue: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	2

Ability to achieve electrode contact with cardiac tissue: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	2

Ability to achieve electrode contact with cardiac tissue: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	18

Ability to achieve electrode contact with cardiac tissue: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	8

Electrodes spacing: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Workflow Secondary · 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.

Ability to reduce fluoroscopy: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to reduce fluoroscopy: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to reduce fluoroscopy: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Ability to reduce fluoroscopy: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	10

Ability to reduce fluoroscopy: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	6

Ability to reduce fluoroscopy: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	10

Ability to reduce fluoroscopy: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	5

Time for pre-procedure mapping: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Catheter Visualization Secondary · 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.

Visualization under fluoroscopy: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Visualization under fluoroscopy: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Visualization under fluoroscopy: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Visualization under fluoroscopy: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Visualization under fluoroscopy: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	7

Visualization under fluoroscopy: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	9

Visualization under fluoroscopy: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	15

Visualization in CARTO 3: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Catheters Interactions Secondary · 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.

With CARTO 3 System: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

With CARTO 3 System: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

With CARTO 3 System: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

With CARTO 3 System: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	0

With CARTO 3 System: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	4

With CARTO 3 System: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	12

With CARTO 3 System: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	15

EP Lab recording equipment: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Number of Responders for Physician Assessment for Arrhythmogenicity Secondary · 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.

Compared to the PENTARAY catheter?: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Compared to the PENTARAY catheter?: Score 2

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Compared to the PENTARAY catheter?: Score 3

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Compared to the PENTARAY catheter?: Score 4

Group	Value	95% CI
OPTRELL Mapping Catheter	2

Compared to the PENTARAY catheter?: Score 5

Group	Value	95% CI
OPTRELL Mapping Catheter	5

Compared to the PENTARAY catheter?: Score 6

Group	Value	95% CI
OPTRELL Mapping Catheter	10

Compared to the PENTARAY catheter?: Score 7

Group	Value	95% CI
OPTRELL Mapping Catheter	14

Compared to other competitive multielectrode catheters?: Score 1

Group	Value	95% CI
OPTRELL Mapping Catheter	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 72 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OPTRELL Mapping Catheter

Serious: 3/31 (10%)

Deaths: 0/31

Serious adverse events (4 terms)

Reaction	System	OPTRELL Mapping Catheter
Anaemia	Blood and lymphatic system disorders	—
Catheter site injury	General disorders	—
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	—
Peripheral artery haematoma	Vascular disorders	—

Other adverse events (8 terms — click to expand)

Reaction	System	OPTRELL Mapping Catheter
Fatigue	General disorders	—
Left ventricular dilatation	Cardiac disorders	—
Left ventricular dysfunction	Cardiac disorders	—
Abdominal pain, upper	Gastrointestinal disorders	—
Ear infection	Infections and infestations	—
Lower limb fracture	Injury, poisoning and procedural complications	—
Paraesthesia	Nervous system disorders	—
Anxiety disorder	Psychiatric disorders	—

Most-reported serious reactions: Anaemia, Catheter site injury, Vascular pseudoaneurysm, Peripheral artery haematoma.

Data from ClinicalTrials.gov NCT04983797 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and feasibility of a novel multielectrode array catheter in mapping atrial and ventricular arrhythmias with high density: results from the multicenter OPTIMUM study.
Vijgen J, Račkauskas G, Dilling-Boer D, Sarkozy A, et al · · 2023 · cited 1× · PMID 37227536 · DOI 10.1007/s10840-023-01568-y

Verify or expand the search:

Other recruiting trials for Scar-related Atrial Tachycardia

Currently open trials in the same condition.

NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting

Other Biosense Webster, Inc. trials

Trials by the same sponsor.

NCT07527299 — A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior · NA · not yet recruiting
NCT07523750 — A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants Wit · NA · not yet recruiting
NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
NCT07428564 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF · NA · not yet recruiting
NCT07227532 — A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Cathe · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04983797 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biosense Webster, Inc.
Last refreshed: 3 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04983797.

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