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Primary Results1
The primary safety and effectiveness endpoints were met.
3.6%
Primary Adverse Event Ratea
The primary adverse event rate was 3.6% (14% performance goal).
1.8%
Catheter-Related Primary Adverse Event Rate
The catheter-related adverse event rate was low at 1.8%.
77%
Primary Effectiveness Rateb
The 12-month freedom from documented AF/AFL/AT recurrence and freedom from failure modes was 77% (50% performance goal).
86%
Clinical success
(freedom from symptomatic recurrence)
The 12-month freedom from documented, symptomatic recurrence was 86%.
92%
Freedom From Repeat Ablation
The 12-month freedom from repeat ablation was 92%.
Quality-of-Life Results2
88% of participants achieved clinically meaningful improvements in quality-of-life based on patient-reported AFEQT questionnaire responses.c
99%
Improvement in control of AF at 12-months postablation.
93%
Improvement in relief of AF symptoms at 12-months postablation.
Healthcare Utilization Results2
The 12-month freedom from cardiovascular hospitalization was 89%. Q-FFICIENCY participants experienced significant reduction in healthcare utilization.
-80%
Reduction in Class III AAD use 6–12 months postablation compared to baseline (P<0.0001).
-94%
Cardioversion use during evaluation period compared to 12-months preablation (P<0001).
Population
- Single-arm, prospective, multicenter, nonrandomized, investigational device exemption study
- 22 US institutions
- 166 Evaluable participants with symptomatic paroxysmal AF
Follow-Up
12-month follow-up with stringent monitoring (3-month blanking, 9-month evaluation)
- ECG (1-, 3-, 6-, and 12-month visits)
- TTM (weekly 3–5 months, monthly 6–12 months, when symptomatic)
- 24-h Holter (12-month visit)