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

This is an image of the 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%).

This graph shows the mental and physical health improvements 12 months after an Arctic Front cryoballoon procedure.
This graph shows 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.

Learn more about the impact of the Arctic Front cryoballoon ablation for the treatment of persistent atrial fibrillation featuring a discussion of the clinical evidence supporting pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) and STOP Persistent AF trial results.


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    

Educational resources on Medtronic Academy

Access detailed product information, including specification sheets, videos, and presentations.

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