NCT04545619

Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.

Completed NA Results posted Last updated 29 June 2025

What this trial tests

NA trial testing QDOT MICRO System in Atrial Fibrillation in 40 participants. Completed in 9 November 2021.

Timeline

2 October 2020

Primary endpoint
9 November 2021

9 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	40
Start date	2 October 2020
Primary completion	9 November 2021
Estimated completion	9 November 2021
Sites	1 location across Canada

Drugs / interventions tested

• QDOT MICRO System

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Biosense Webster, Inc. — full company profile →

Who can join

18 and older, any sex, with 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 Who Achieved Acute Procedural Success Primary · Up to 104 days

Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure.

Group	Value	95% CI
QDOT-nGEN Catheter	37

Number of Participants With Adverse Events (AEs) Secondary · Up to 104 days

Number of participants with AEs were reported. An AE was any untoward medical occurrence whether or not related to the study device or ablation procedure.

Group	Value	95% CI
QDOT-nGEN Catheter	9

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 104 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

QDOT-nGEN Catheter

Serious: 1/39 (3%)

Deaths: 0/39

Serious adverse events (1 terms)

Reaction	System	QDOT-nGEN Catheter
Pyrexia	General disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	QDOT-nGEN Catheter
Headache	Nervous system disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Presyncope	Nervous system disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Impaired gastric emptying	Gastrointestinal disorders	—
Odynophagia	Gastrointestinal disorders	—
Cystitis	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Pericardial effusion	Cardiac disorders	—
Hypothyroidism	Endocrine disorders	—
Procedural pain	Injury, poisoning and procedural complications	—
Dysuria	Renal and urinary disorders	—
Haematoma	Vascular disorders	—

Most-reported serious reactions: Pyrexia.

Data from ClinicalTrials.gov NCT04545619 adverse events section.

Sponsor's own description

This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.

Publications & conference data

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

1. Safety and acute performance of atrial fibrillation ablation using a temperature-controlled, very high-power short-duration catheter and a new radiofrequency generator.
   Macle L, Nair GM, Skanes A, Aguilar M, et al · · 2024 · cited 2× · PMID 37930503 · DOI 10.1007/s10840-023-01652-3