ATTEST CLINICAL STUDY
elderly patient

ATTEST CLINICAL STUDY

The ATTEST Clinical Study1

was the first randomized controlled study to introduce progression from paroxysmal to persistent AF as a clinical endpoint in an AF study. ATTEST demonstrated that early RF catheter ablation—as part of standard-of-care AF management including antiarrhythmic drugs—is superior to guideline-directed antiarrhythmic drug therapy alone in delaying AF progression.

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The study included 29 centers across 13 countries.

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255 patients ≥60 years old with paroxysmal AF ≥2 years participated in the study.

Superiority of RF Ablation Over Antiarrhythmic Drug Therapy Alone to Delay AF Progression

Kaplan-Meier estimate of disease progression for patients treated with radiofrequency ablation versus antiarrhythmic drugs.

The superiority of RF ablation over antiarrhythmic drug therapy alone in delaying disease progression was observed at 1-year follow-up and strengthened by the 3-year follow-up.

 

Antiarrhythmic Drug Therapy and Older Age Were Associated With AF Progression

Cox model for disease progression among patients treated with radiofrequency ablation versus patients treated with antiarrhythmic drugs, and patients 60-64 years old versus patients >65 years old.

Treatment modality and age were associated with AF progression, suggesting that early RF ablation can delay disease progression.


Patient Inclusion and Exclusion Criteria

Key Inclusion Criteria

  • ≥60 years old with paroxysmal AF ≥2 years
  • ≥2 episodes over the 6 months preceding enrollment
  • Failed treatment with 1–2 antiarrhythmic drugs
  • HATCH score 1–4

Key Exclusion Criteria

  • Reversible AF
  • Previous diagnosis of persistent/permanent AF/AT
  • Cardioversion >48 h after onset of AF/AT
  • Recent cardiovascular events

Study Design and Patient Follow-Up

Study design and patient follow-up schedule

Abbreviations, Footnotes, and References

AAD, antiarrhythmic drug; AF, atrial fibrillation; AT, atrial tachycardia; ECG, electrocardiogram; FU, follow-up; HATCH score: hypertension = 1, age >75 = 1, transient ischemic attack or stroke = 2, chronic obstructive pulmonary disease = 1, heart failure = 2; ITT, intention to treat; PP, per protocol; RF, radiofrequency; TTM, transtelephonic monitoring. 

a RF ablation was performed with noncontact force- and contact force-sensing catheters (NAVISTAR® THERMOCOOL ® Catheter, THERMOCOOL® SF NAV Catheter Bi-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH ® Bi-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH ® Uni-Directional Navigation Catheter, NAVISTAR RMT THERMOCOOL ® Catheter) in conjunction with a 3-dimensional electroanatomic mapping system (CARTO® 3, CARTO® XP, or CARTO® RMT).

b Transtelephonic monitoring transmission per specified schedule or whenever patients experienced symptoms. Once AF/AT was identified, daily TTM was initiated for 7 consecutive days.

1. Kuck K-H, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: The randomized controlled Atrial Fibrillation Progression Trial (ATTEST). Europace. 2021;23(3):362-369.

THERMOCOOL® Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® 3 Systems (excluding NAVISTAR™ RMT THERMOCOOL™ Catheter).

Important information: Prior to use, refer to the instructions for use supplied with the device for indications, contraindications, side effects, warnings and precautions. 
Caution: US law restricts this device to sale by or on the order of a physician.

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