N/A Completed N=40 Other

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

Atrial Fibrillation

Source: ClinicalTrials.gov NCT04545619 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Dec 2022

Primary outcomePrimary: Number of Participants Who Achieved Acute Procedural Success — 37 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Achieved Acute Procedural Success	37	—
SECONDARY Number of Participants With Adverse Events (AEs)	9	—

Eligibility Criteria

Inclusion Criteria

Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation.
Age 18 or older.
Signed the Patient Informed Consent Form (ICF).

Exclusion Criteria

If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks.
Presence of a myxoma or an intracardiac thrombus.
Presence of prosthetic valves.
Presence of active systemic infection
Patient with an interatrial baffle or patch
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04545619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.