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Clinical Data


CONVERGE IDE Study Design

The CONVERGE IDE trial enrolled 153 patients (88 persistent and 65 long-standing persistent patients) at 27 locations (25 in the United States and 2 in the United Kingdom). Patients were randomized at a rate of 2:1 and received either Hybrid AF Convergent therapy or endocardial RF catheter ablation alone. David DeLurgio, MD, of Emory St. Joseph’s Hospital in Atlanta, Georgia, was the trial’s national principal investigator.

CONVERGE IDE Trial Findings

The Hybrid AF Convergent procedure is the only proven therapy to treat patients who have been in AF for more than one year.1,2 Both 12-month (Table 1) and 18-month (Table 2) data from the CONVERGE IDE trial show that the Hybrid AF Convergent procedure provides durable, long-lasting efficacy.

Table 1: Effectiveness Endpoints for Long-Standing Persistent AF Sub-group—12-Month Follow-Up2

Parameter Hybrid AF Convergent Ablation Arm
(N=38)
Endocardial RF Catheter Ablation Arm
(N=27)
Difference
(Hybrid – Endocardial catheter ablation)
Freedom from AF/AFL/AT from 3-month blanking period through 12 months*
n%, (95% Confidence Interval)
65.8%
(50.7%, 80.9%)
37.0%
(18.8%, 55.3%)
28.8%
in favor of Hybrid
≥90% burden reduction at 12 months*
n%, (95% Confidence Interval)
78.9%
(66.0%, 91.9%)
46.2%
(27.0%, 65.3%)
32.7%
in favor of Hybrid
Freedom from AF through 12 months *
n%, (95% Confidence Interval)
71.1%
(56.6%, 85.5%)
37.0%
(18.8%, 55.3%)
34.1%
in favor of Hybrid
*Without new/ increased dosage of previously failed class I/III AADs
AADs: anti-arrhythmic drugs; AF: atrial fibrillation; AFL: atrial flutter; AT: atrial tachycardia

 

Table 2: Effectiveness Endpoints for Long-Standing Persistent AF Sub-group—18-Month Follow-Up2

Parameter Hybrid AF Convergent Ablation Arm
(N=38)
Endocardial RF Catheter Ablation Arm
(N=27)
Difference
(Hybrid – Endocardial catheter ablation)
Freedom from AF/AFL/AT from 3-month blanking period through 18 months*
n%, (95% Confidence Interval)
60.5%
(45.0%, 76.1%)
25.9%
(9.4%, 42.5%)
34.6%
in favor of Hybrid
≥90% burden reduction at 18 months*
n%, (95% Confidence Interval)
73.0%
(58.7%, 87.3%)
36.0%
(17.2%, 54.8%)
37.0%
in favor of Hybrid
Freedom from AF through 18 months *
n%, (95% Confidence Interval)
68.4%
(53.6%, 83.2%)
29.6%
(12.4%, 46.9%)
38.8%
in favor of Hybrid
*Without new/ increased dosage of previously failed class I/III AADs
AADs: anti-arrhythmic drugs; AF: atrial fibrillation; AFL: atrial flutter; AT: atrial tachycardia

Data based on the post-hoc analysis of long-standing persistent AF sub-groups (N=65).


Hybrid AF Convergent Procedure in Electroanatomic Heterogeneous Cohort3

In this challenging cohort of patients with refractory, long-standing persistent atrial fibrillation (LSPAF), the probability of long-term arrhythmia-free survival was significantly higher with Hybrid AF Convergent ablation (p=0.003).

The study by Maclean, et al., enrolled 43 consecutive patients with LSPAF, who were treated with the Hybrid AF Therapy. Outcomes were compared with a matched group of 43 patients who had catheter ablation alone. Both groups underwent multiple catheter ablations as needed.

Parameter Hybrid AF Convergent Arm Catheter Ablation Arm
AF-Free Survival with AADs at 12 months
P = 0.002
60.5% 25.6%
AF-Free Survival with AADs at 30.5 months
P = 0.016
58.1% 30.2%
AF-Free Survival without AADs at 30.5 months
P = 0.036
32.5% 11.6%
Although the survival data are lower than those reported in other studies, the authors suggest this may be due to electroanatomic heterogeneity of the study cohort, which included patients with:
  • Severe left ventricular systolic dysfunction
  • Cardiomyopathy
  • Pacemakers
  • Prior unsuccessful rhythm control in over one-third of cases

While the Hybrid AF Convergent group had an increased incidence of atrial tachycardia (AT, 32.6%) none of these arrhythmias originated from the posterior wall. Instead, the origin of the AT prompted the authors to suggest consideration of empirical cavotricuspid isthmus (CTI) lines.

This study reveals that in patients with LSPAF, the Hybrid AF Convergent procedure is associated with increased freedom from AF at one year—and improved arrhythmia-free survival long term—versus endocardial catheter ablation alone.

AADs: anti-arrhythmic drugs


Hybrid AF CryoConvergent Therapy4

This study by Makati, et al., showed that using endocardial cryothermy in Hybrid AF Convergent procedures achieved marked reductions in AF burden, even in long-standing persistent AF (LSPAF). Most Hybrid AF Convergent studies use radiofrequency as the endocardial and epicardial energy. This study reports the safety and efficacy of the Hybrid AF Convergent procedure using endocardial cryothermy.

Method: Retrospective analysis of 226 TRAC-AF Registry patients (2011-2018) who underwent epicardial RF ablation and endocardial cryothermy.

Parameter All patients
(mean 15.4 ± 6.5 months)
Persistent AF
(mean 14.7 ± 6.1 months)
LSPAF
(mean 16.8 ± 6.3 months)
Free of AF/AFL/AT: on or off previously failed AADs 75% 85% 70%
Free of AF/AFL/AT: off amiodarone 70% 84% 64%
Free of AF/AFL/AT: off AADs 53%    
AF Burden Reduction (3-12 months) 98.9% 99.3% 98.5%
AF Burden Reduction (12-24 months) 91.5% 89.3% 92.5%

Results indicate Hybrid AF Convergent using cryo energy provides a promising solution for treatment of persistent AF and LSPAF, evidenced by relatively low AF recurrence rates and marked AF burden reduction after treatment—even in LSPAF patients.

AF: atrial fibrillation; AFL: atrial flutter; AT: atrial tachycardia; AADs: anti-arrhythmic drugs

  1. DeLurgio, D.B., et al. (2021). Hybrid epicardial-endocardial RF ablation vs. endocardial catheter ablation for long-standing persistent atrial fibrillation treatment: Results from CONVERGE randomized controlled trial. International AF Symposium.
  2. IFU for EPi-Sense® Guided Coagulation System Data: PMA# P200002.
  3. Maclean, E., et al. (2020). The CONVERGENT procedure versus catheter ablation alone in long-standing persistent atrial fibrillation: a single center, propensity-matched cohort study. International Journal of Cardiology, 303,49-53.
  4. Makati, K. J., et al. (2020). Safety and efficacy of Convergent Hybrid procedure using cryo as endocardial energy source for the treatment of atrial fibrillation. Circulation: Arrhythmia and Electrophysiology. 13, e008556.

    This material is intended to provide objective information about the use of AtriCure's Technology, including where and how the device can be used within the continuum of care. The enclosed publication includes information regarding patients with persistent or long-standing persistent atrial fibrillation treated with the EPi-sense technology in a hybrid procedure. This material is being provided to demonstrate use of the EPi-Sense system in the treatment of long-standing atrial fibrillation and its clinical outcomes. This publication was chosen for this purpose because the study summarized herein utilized a trial design similar to that used in the CONVERGE IDE study which supported FDA approval of the EPi-Sense System for the indication stated above.
PM-US-0245B-0323-G