Cardiac ablation and mapping

STOP Persistent AF trial

A study to evaluate the safety and effectiveness of the Medtronic Arctic Front™ cryoablation system for treating drug-refractory, symptomatic, persistent atrial fibrillation.

Alert Indications, Safety, and Warnings

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Study purpose and design

The STOP Persistent AF trial is the first and largest, prospective, multicenter, single-arm study with prespecified performance goals to assess the safety and efficacy of pulmonary vein isolation (PVI) using the Medtronic Arctic Front Advance™ cryoballoon for patients with drug-refractory, symptomatic, persistent AF. The trial included 165 patients treated at 25 sites across the United States, Canada, and Japan.¹

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Arctic Front cryoballoon encircled on a gray background

Key findings

54.8%

Primary effectiveness endpoint met

Primary efficacy endpoint of 54.8% exceeded prespecified performance goal (P < 0.001).

0.6%

Primary safety endpoint met

Primary safety endpoint rate of 0.6% was below prespecified performance goal (P = 0.002). Only one primary safety event occurred and was unrelated to study device.

121 minutes

Efficiency outcomes

Short and predictable procedure times of 121 ± 46 minutes

Quality-of-life outcomes

86.8% secondary endpoint assessments of quality of life demonstrated significant improvements by 12 months post-ablation (P < 0.001) with a high rate of freedom from repeat ablation (86.8%).

Graph showing the mental and physical health improvements 12 months after an Arctic Front cryoballoon procedure

Graph showing the symptoms reported by patients twelve months after an Arctic Front cryoballoon procedure

Watch the scientific exchange video.

Learn more about the Impact of Arctic Front™ Cryoballoon Ablation for the Treatment of Persistent Atrial Fibrillation featuring a discussion of the clinical evidence supporting PVI for persistent AF and STOP Persistent AF trial results.

Dr. Hugh Calkins
Dr. Vivek Reddy
Dr. Wilber Su

Log in to Medtronic Academy to view the video.

Endpoint definitions

Primary efficacy endpoint

Success at 12 months > 40% performance goal

Acute procedural success (cryoballoon PVI only)
Freedom from AF/AT/AFL ≥ 30 sec after 90-day blanking
No class I or III AAD dose initiation/increase after blanking

Primary safety endpoint

Safety event rate < 13% performance goal

Within 7 days: death, transient ischemic attack, cerebrovascular accident, major bleeding that requires transfusion, myocardial infarction, cardiac perforation, tamponade, or pericardial effusion
Within 12 months: PV stenosis or AE fistula
At 12 months: unresolved PNI

Study population

Key inclusion criteria

Symptomatic, persistent AF defined as a continuous, sustained episode lasting longer than 7 days but ≤ 6 months
Failure or intolerance of at least one AAD
At least 18 years of age

Key exclusion criteria

Prior left atrial ablation or surgery
Stroke/transient ischemic attack within 6 months of enrollment
Left ventricular ejection fraction ≤ 35%
Left atrial diameter > 5.0 cm

Study recurrence monitoring

	Pre-procedure	Blanking period 6W	3 months	6 months	12 months
Weekly and symptomatic tele-ECG monitoring			➜	➜	➜
Telephone follow-up		◾
In-office 12-lead ECG			◾	◾	◾
In-office 24-hour Holter				◾	◾
Quality-of-life survey	◾			◾	◾

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Educational resources on
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Reference

Su WW, Reddy VY, Bhasin K, et al. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020;17(11):1841–1847.