CLINICAL STUDY

Q-FFICIENCY

CLINICAL STUDY

Q-FFICIENCY

The QDOT MICRO™ Catheter Investigational Device Exemption Study

The QDOT MICRO™ Catheter Investigational Device Exemption Study

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).

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Population

  • Single-arm, prospective, multicenter, nonrandomized, investigational device exemption study
  • 22 US institutions
  • 166 Evaluable participants with symptomatic paroxysmal AF
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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)