CompletedNot Applicable

An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System

Lithuania16 participantsStarted 2018-05-01

Plain-language summary

A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 and \< 75 years.
✓. Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:
✓. Subject is able and willing to give informed consent.
✓. Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

Exclusion criteria

✕. Documented left atrial thrombus or another abnormality which precludes catheter introduction.
✕. Documented ejection fraction (EF) \< 40%.
✕. Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant \[NOAC\]).
✕. Unstable angina or ongoing myocardial ischemia.
✕. Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
✕. Congenital heart disease where the underlying abnormality increases the risk of the ablation.
✕. Pulmonary hypertension (mean pulmonary artery pressure \[mPAP\] \> 50 mmHg)
✕. Enrollment in any other ongoing study protocol that would interfere with this study.

What they're measuring

Number of Subjects With a Primary Safety Event

Timeframe: 90 days

Number of Positive (Affirmative) Product Performance Responses

Timeframe: Index ablation procedure

Trial details

NCT IDNCT04210622

SponsorMedtronic Cardiac Ablation Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-04

Results submitted2025-04-23

View on ClinicalTrials.gov More Atrial Fibrillation trials