CompletedNot Applicable

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

United States402 participantsStarted 2012-06-26

Plain-language summary

The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Documented PAF:
✓. Age 18 years or older
✓. Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.

Exclusion criteria

✕. Any previous left atrial (LA) ablation (except permissible retreatment subjects)
✕. Any previous LA surgery
✕. Current intracardiac thrombus (can be treated after thrombus is resolved)
✕. Presence of any pulmonary vein stents
✕. Presence of any pre-existing pulmonary vein stenosis
✕. Pre-existing hemidiaphragmatic paralysis
✕. Anteroposterior LA diameter \> 5.5 cm by TTE
✕. Presence of any cardiac valve prosthesis

What they're measuring

Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months

Timeframe: Through 36 months

Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months

Timeframe: 12 Months

Trial details

NCT IDNCT01456949

SponsorMedtronic Cardiac Ablation Solutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-30

Results submitted2018-11-21

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation (PAF) trials