Who is sponsoring NCT03624881?

NCT03624881 is sponsored by Biosense Webster, Inc..

What drugs are being tested in NCT03624881?

Interventions in NCT03624881: Catheter ablation with EPU.

What condition does NCT03624881 study?

NCT03624881 studies Paroxysmal Atrial Fibrillation.

Is NCT03624881 still recruiting?

NCT03624881 is currently completed. Last updated 3 July 2023.

Are results published for NCT03624881?

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

NCT03624881

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

Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)

Completed Phase 4 Results posted Last updated 3 July 2023

What this trial tests

Phase 4 trial testing Catheter ablation with EPU in Paroxysmal Atrial Fibrillation in 333 participants. Completed in 28 June 2021.

Timeline

4 September 2018

Primary endpoint
28 June 2021

28 June 2021

Quick facts

Lead sponsor	Biosense Webster, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	333
Start date	4 September 2018
Primary completion	28 June 2021
Estimated completion	28 June 2021
Sites	41 locations across United States

Drugs / interventions tested

Catheter ablation with EPU

Conditions studied

Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with 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 Primary Adverse Events (PAEs) Primary · Up to 12 months

A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. 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 medi

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	11
VISITAG SURPOINT Module ST Catheter With EPU	3

Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic) Primary · Up to 12 months

Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation \[AF\], atrial flutter \[AFL\], and atrial tachycardia \[AT\]) were reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	173
VISITAG SURPOINT Module ST Catheter With EPU	34

Percentage of Participants With Cumulative PAEs Secondary · Up to 12 months

A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. 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 p

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	4.3
VISITAG SURPOINT Module ST Catheter With EPU	6.3

Number of Participants With Unanticipated Adverse Device Effects (UADEs) Secondary · Up to 12 months

Number of participants with UADEs was reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	0
VISITAG SURPOINT Module ST Catheter With EPU	0

Number of Participants With Serious Non-Primary AEs Secondary · Up to 12 months

Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. 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
VISITAG SURPOINT Module STSF Catheter With EPU	42
VISITAG SURPOINT Module ST Catheter With EPU	3

Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset Secondary · Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)

Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (\>=) 2 grams per deciliter (g/dL), transfusion of \>= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding eve

Major (0-7 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	0
VISITAG SURPOINT Module ST Catheter With EPU	0

Major (8-30 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	0
VISITAG SURPOINT Module ST Catheter With EPU	0

Major (>=31 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	0
VISITAG SURPOINT Module ST Catheter With EPU	0

CRNM (0-7 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	4
VISITAG SURPOINT Module ST Catheter With EPU	0

CRNM (8-30 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	0
VISITAG SURPOINT Module ST Catheter With EPU	0

CRNM (>=31 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	3
VISITAG SURPOINT Module ST Catheter With EPU	0

Minor (0-7 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	17
VISITAG SURPOINT Module ST Catheter With EPU	1

Minor (8-30 Days)

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	2
VISITAG SURPOINT Module ST Catheter With EPU	0

Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure Secondary · End of the Procedure (up to 12 months)

Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	98.8
VISITAG SURPOINT Module ST Catheter With EPU	100

Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection Secondary · Up to 12 months

Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	72.0
VISITAG SURPOINT Module ST Catheter With EPU	85.7

Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins Secondary · Up to 12 months

Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	16.9
VISITAG SURPOINT Module ST Catheter With EPU	7.1

Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement Secondary · Up to 12 months

Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV).

LPV: Anterior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	4.2
VISITAG SURPOINT Module ST Catheter With EPU	2.4

LPV: Superior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	3.5
VISITAG SURPOINT Module ST Catheter With EPU	0.0

LPV: Ridge

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	3.9
VISITAG SURPOINT Module ST Catheter With EPU	0.0

LPV: Posterior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	7.5
VISITAG SURPOINT Module ST Catheter With EPU	0.0

LPV: Inferior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	1.3
VISITAG SURPOINT Module ST Catheter With EPU	2.2

RPV: Anterior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	11.6
VISITAG SURPOINT Module ST Catheter With EPU	4.3

RPV: Superior

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	5.7
VISITAG SURPOINT Module ST Catheter With EPU	12.5

RPV: Ridge

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	9.1
VISITAG SURPOINT Module ST Catheter With EPU	0.0

Number of Participants Who Underwent Repeat Ablation Procedures Secondary · Up to 12 months

Number of participants who underwent repeat ablation procedures were reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	14
VISITAG SURPOINT Module ST Catheter With EPU	3

Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure Secondary · Up to 12 months

Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported.

Group	Value	95% CI
VISITAG SURPOINT Module STSF Catheter With EPU	57.1
VISITAG SURPOINT Module ST Catheter With EPU	100

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VISITAG SURPOINT Module STSF Catheter With EPU

Serious: 53/261 (20%)

Deaths: 2/261

VISITAG SURPOINT Module ST Catheter With EPU

Serious: 6/49 (12%)

Deaths: 0/49

Serious adverse events (64 terms)

Reaction	System	VISITAG SURPOINT Module ST…	VISITAG SURPOINT Module ST…
Pneumonia	Infections and infestations	—	—
Atrial flutter	Cardiac disorders	—	—
Pericarditis	Cardiac disorders	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Bradycardia	Cardiac disorders	—	—
Palpitations	Cardiac disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Sepsis	Infections and infestations	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac Tamponade/Perforation	Cardiac disorders	—	—
Major Vascular Access Complication / Bleeding	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Intracardiac thrombus	Cardiac disorders	—	—
Mitral valve incompetence	Cardiac disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—

Other adverse events (178 terms — click to expand)

Reaction	System	VISITAG SURPOINT Module ST…	VISITAG SURPOINT Module ST…
Chest pain	General disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Hypertension	Vascular disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Palpitations	Cardiac disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Haematoma	Vascular disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Fatigue	General disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Atrial tachycardia	Cardiac disorders	—	—
Pericarditis	Cardiac disorders	—	—
Chest discomfort	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Hypotension	Vascular disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Supraventricular extrasystoles	Cardiac disorders	—	—
Ventricular extrasystoles	Cardiac disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Corona virus infection	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Urinary retention	Renal and urinary disorders	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—
Drug hypersensitivity	Immune system disorders	—	—
Bradycardia	Cardiac disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—
Visual impairment	Eye disorders	—	—
Vitreous floaters	Eye disorders	—	—
Large intestine polyp	Gastrointestinal disorders	—	—

Most-reported serious reactions: Pneumonia, Atrial flutter, Pericarditis, Osteoarthritis, Cardiac failure, Atrial fibrillation, Bradycardia, Palpitations.

Data from ClinicalTrials.gov NCT03624881 adverse events section.

Sponsor's own description

Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.

Publications & conference data

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

Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study.
Di Biase L, Monir G, Melby D, Tabereaux P, et al · · 2022 · cited 22× · PMID 36137711 · DOI 10.1016/j.jacep.2022.06.007

Verify or expand the search:

Other recruiting trials for Paroxysmal Atrial Fibrillation

Currently open trials in the same condition.

NCT07535268 — REPRESENT-PF Registry · recruiting
NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
NCT07281898 — Burst Stimulation for Paroxysmal Atrial Fibrillation · NA · recruiting
NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
NCT06765356 — Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias · Phase 4 · active not 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 NCT03624881 (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/NCT03624881.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing