Hybrid AF Therapy - Clinical Data

Quick Links to Content Below:

Hybrid AF™ CONVERGE Trial Overview
Procedural Performance
Real World Evidence
References
Indications for Use

Hybrid AF CONVERGE Trial Overview1,2

  • Pivotal trial designed to evaluate the safety and efficacy of the EPi-Sense® Guided Coagulation System for the treatment of symptomatic persistent atrial fibrillation (AF) as compared to a standalone endocardial catheter ablation​
  • To demonstrate safety of the Hybrid Convergent procedure for the treatment of symptomatic persistent and long-standing persistent AF​
  • 153 subjects
    88 persistent and 65 long-standing persistent patients​
  • 27 sites
    25 in the US, 2 in the UK
  • Patients between 18 and 80 years of age, with symptomatic persistent AF, refractory or intolerant to at least one class I/III anti-arrhythmic drug and with a left atrium size of ≤ 6.0 cm. There was no limitation on duration of AF.​
 

Hybrid Convergent Procedure Demonstrates an Acceptable Safety Profile1,2

2.9% at 7 Days

Not pre-specified by protocol
in line with endocardial studies

7.8% at 30 Days

Pre-specified by CONVERGE
protocol

No Deaths | No Cardiac Perforations | No Atrioesophageal Fistulas​

Safety Events reported on all treated patients in Hybrid Convergent arm (n=102):

  • 1 Stroke (slightly slower left facial movement, did not have debilitating effect)
  • 1 Phrenic nerve injury, resolved
  • 1 Bleed
  • 1 Bleed with late pericardial effusion
  • 1 Transient ischemic attack
  • 4 Cardiac tamponade (did not result in hemodynamic compromise)
     

Procedural Performance

99%

Procedural success with Hybrid AF Therapy*
(98% with endocardial ablation alone)

*Procedural success defined as lesion pattern and pulmonary vein isolation as demonstrated by entrance and /or exit block.​

20%

Improved efficiency with 41 Minutes saved† in the Hybrid AF endocardial procedure compared to catheter ablation alone
†Average time savings

No significant difference in fluoroscopy time between Hybrid Convergent and endocardial ablation alone​

View publication

 

Greater Freedom from AF and AF Burden Reduction in Patients with LSPAF with Hybrid Convergent vs Endocardial Ablation Alone, and Sustained Through 18 Months (7-day Holter)1,2

freedom from AF and AF burden reduction

Greater Freedom from Atrial Arrhythmia with and/or without Anti-arrhythmic Drugs* in LSPAF with Hybrid Convergent vs Endocardial Ablation Alone, and Sustained Through 18 months (7-day Holter)1,2

Freedom from atrial arrhythmia

Real World Evidence with Hybrid AF Therapy

 

Hybrid Convergent Demonstrates Improved AF-Free Survival3

This prospective, single site, observational post-market study evaluated atrial fibrillation (AF)-free survival at 12 months and at 3 years among long-standing persistent AF (LSPAF) patients who underwent the Hybrid Convergent procedure. Outcomes were compared to a matched cohort of 43 patients who underwent catheter ablation alone.  Baseline characteristics were similar between groups.

Study duration:  1-3 years 

Sample Size:  N=43 in Hybrid Convergent arm with matched cohort of N=43 patients in endocatheter ablation arm

Results: The Hybrid Convergent procedure was associated with improved AF-Free survival on and off antiarrhythmic drugs (AADs) versus endocatheter ablation alone at 12 months and at 30.5±13.3 months of follow-up.

Both groups underwent multiple catheter ablations as needed.

View Publication

Hybrid improves AF free survival

Longer-term AF Burden Reduction with Hybrid Convergent Ablation4

This multicenter, retrospective analysis of 226 patients in the TRAC-AF Registry evaluated safety and atrial fibrillation (AF) burden outcomes after Hybrid Convergent procedure with cryo endocardial pulmonary vein isolation. 
 

Study Duration: 12 and 24-month follow-up following a 3-month blanking period from the index procedure

Sample Size: N=226 who underwent Hybrid Convergent procedure with endocardial cryothermy ablation between Nov 2011 and May 2018.

Results: Hybrid Convergent with cryo endocardial ablation resulted in low atrial fibrillation (AF) recurrence rates and marked AF burden reduction at 12 and 24-months post-procedure. 

98.5% or greater
AF Burden Reduction

12 months

89% or greater
AF Burden Reduction 

12 to 24 months

Secondary analysis demonstrating AF burden reduction in patients continuous monitored by implantable loop recorder, implantable pacemaker or defibrillator
 

Freedom from Atrial Arrhythmia achieved in most patients

Sustained AF Burden Reduction with Continuous Rhythm Monitoring5

This single center, retrospective analysis evaluated long term AF-free survival among patients with either persistent or long-standing persistent atrial fibrillation (LSPAF) who underwent the Hybrid Convergent procedure.  

Study Duration: Mean duration of follow-up was 501 ± 355 days.

Sample Size: N=113 consecutive patients; 88% had either persistent AF or long-standing persistent AF. Most patients (n=92) had continuous rhythm monitoring. 

94% of patients had < 5% AF burden at last follow-up 

64% of patients were off antiarrhythmic drugs at the last follow-up 

53% of patients were free from any AF or atrial tachycardia episode lasting more than 30 sec at 12 months
 

View Publication

 

Longer-term Freedom from Atrial Arrhythmias with Hybrid Convergent Procedure6

This retrospective analysis evaluated 31 patients with persistent atrial fibrillation (AF) who underwent the Hybrid Convergent procedure at a single institution between Oct 2013 and Mar 2017. 

Study duration: Median follow up was 17.7 months

Sample Size: N=31 (16 long-standing persistent AF, 15 persistent AF)

Freedom from Atrial Arrhythmia Recurrence with or without Anti-arrhythmic Drugs

Type of Arrhythmia

At 2 Years

AF Only

71%

Atrial Tachyarrhythmias*

52%

*After 90-day blanking period; atrial tachyarrhythmias include atrial fibrillation  and atrial flutter

At the 2-year follow-up, mean time of recurrence of AF/AFL and AF alone 491 ± 187 days and 417 ± 169 days, respectively.

A total of 16.1% of patients in this cohort had pre-existing hypertrophic cardiomyopathy. These patients are known to have higher recurrence rates and need for antiarrhythmic drugs (AADs) for longer periods of time.

View Publication

 

Key Points

Hybrid AF Therapy

Is the first and only FDA-approved device for minimally invasive ablation therapy to treat long-standing persistent AF—the most prevalent and undertreated AF patient population
Safety & Effectiveness

Totality of evidence demonstrates reasonable assurance for use of Hybrid Convergent ablation to treat patients with symptomatic drug-refractory long-standing persistent AF
EP Lab Time Savings

41 minutes average time saved in Hybrid Convergent endocardial procedure arm of the Hybrid AF CONVERGE Trial
AF Burden Reduction

Improved reductions in AF burden were demonstrated in the Hybrid AF CONVERGE Trial with similar reductions observed in a real world setting.

 

References

  1. DeLurgio 2020. Circ AE. 13(12):e009288
  2. Instructions For Use for EPi-Sense® Guided Coagulation System, 2021, IFU-0020.B
  3. Maclean E. et al. 2020.  International Journal of Cardiology. 303:49–53
  4. Makati, KJ et al. (2020). Circulation: Arrhythmia and Electrophysiology. 13, e008556.
  5. Larson et al. (2020). J of Cardiovascular Electrophysiology, 31(6): 1270-6
  6. Gulkarov I. et al. 2019. J Card Surg. 34:1037-1043
PM-US-0245C-1224-G
© 2023 Atricure, Inc. All Rights Reserved.