CompletedPhase 4

SMART China, A Multi-center Clinical Registry Study

200 participantsStarted 2015-07-01

Plain-language summary

This is a prospective effectiveness and safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 years or older
✓. Failure of at least one antiarrhythmic drug (AAD) for AF (class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD
✓. Patients with paroxysmal AF eligible for catheter ablation
✓. Patients with symptomatic PAF who have had at least one documented AF episode in the twelve (12) months prior to enrollment. Documentation may include but is not limited to electrocardiogram (ECG), Holter monitor (HM) or transtelephonic monitor (TTM)
✓. Able and willing to comply with all pre-, post- and follow-up testing and requirements
✓. Be able to sign IRB/EC-approved informed consent form

Exclusion criteria

✕. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
✕. Previous surgical or catheter ablation for AF
✕. Any PCI, cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repart or replacement and presence of a prosthetic valve) within the past 2 months.
✕. Any carotid stenting or endarterectomy.
✕. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months)
✕. AF episodes lasting longer than 7 days or terminated via cardioversion
✕. Documented left atrial thrombus on imaging
✕. Uncontrolled heart Failure or New York Heart Association (NYHA) class III or IV

What they're measuring

Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes

Timeframe: 12 Months

Trial details

NCT IDNCT02485925

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-30

Results submitted2018-07-03

View on ClinicalTrials.gov More Atrial Fibrillation trials