The PRECEPT Clinical Study1,2

was the first prospective, multicenter, nonrandomized clinical study designed to determine the safety and effectiveness of contact force–guided radiofrequency ablation of persistent AF using the THERMOCOOL SMARTTOUCH® SF Catheter.

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The study included 27 centers across the United States and Canada.

Patient impact​

381 patients with drug-refractory symptomatic persistent AF participated in the study.

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Clinical Success

80% of persistent AF patients experienced clinical success at 15 months following radiofrequency catheter ablation with the THERMOCOOL SMARTTOUCH® SF Catheter.

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Primary Effectiveness

61% of patients met the primary effectiveness endpoint of freedom from documented recurrence and prespecified failure modes.

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Freedom from Repeat Ablation

The estimated freedom from repeat ablation was 86%.

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Rate of Primary Adverse Events

The 4.7% adverse event rate is similar to that reported in paroxysmal AF studies.3,4

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Quality of Life Outcomes5

Persistent AF patients experienced improvement in quality of life and reduced healthcare utilization rates at 15 months post ablation:

  • 81% of patients self-classified as asymptomatic with respect to AF
  • 29 point increase on quality of life questionnaire (5 point increase considered clinically significant)6
  • 83% decrease in cardioversion
  • 75% reduction in Class I/III AAD use
  • 84% freedom from cardiovascular hospitalization

A Tailored Approach to Ablation1

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PVI-only or PVI+ Ablation

RF ablation with the THERMOCOOL SMARTTOUCH® SF Catheter for isolation of all pulmonary veins was required for all patients (PVI only). Additional ablations were allowed (PVI+) per operator’s discretion.


Patient Inclusion and Exclusion Criteria1

Key Inclusion Criteria

  • Documented symptomatic persistent AF, defined as sustained episodes lasting longer than 7 days but less than 1 year
  • Nonresponse or intolerance to at least one Class I or III AAD

Key Exclusion Criteria

  • Left ventricular ejection fraction <40%
  • Left atrial diameter ≥50 mm
  • Previous AF ablation or cardiac surgery
  • NYHA class III or IV
  • Documented left atrial thrombus within 48 hours of procedure
  • Myocardial infarction within the previous 2 months
  • Thromboembolic event in the previous 12 months