What is the clinical evidence from this study?

Study design: RCT. Population: Symptomatic persistent atrial fibrillation (n=153). Intervention: Convergent hybrid procedure (epicardial and endocardial ablation) vs. Endocardial catheter ablation. Primary outcome: Freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months.

What question did this study set out to answer?

To describe the rationale and design of the CONVERGE trial evaluating whether a hybrid epicardial and endocardial ablation strategy improves outcomes compared with standard endocardial catheter ablation in patients with persistent atrial fibrillation.

February 29, 2020American Heart JournalOpen Access

Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design

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Key result

The CONVERGE trial is a randomized study designed to evaluate the Convergent hybrid procedure versus endocardial catheter ablation in 153 patients with symptomatic persistent atrial fibrillation.

Why the study?

Catheter ablation efficacy for persistent and long-standing persistent AF is low, often requiring multiple procedures, leaving an unmet need for effective treatment.

Does the Convergent hybrid procedure improve freedom from atrial arrhythmias compared to endocardial catheter ablation in patients with symptomatic persistent AF?

Population

153 patients with symptomatic persistent AF refractory or intolerant to at least one Class I/III AAD

Comparison

Convergent hybrid procedure vs endocardial catheter ablation

Design

Prospective, multicenter, open-label 2:1 randomized controlled pivotal study

Follow-up

12-months

Authors

DDDavid B. DeLurgioElectrophysiology EFEdward FergusonCardiovascular Research Associates JGJaswinder GillGuy's and St Thomas' NHS Foundation Trust

Discussion

Member takes

Implication

Cohort data on hybrid ablation in persistent AF; leaves open comparative efficacy versus catheter ablation.

Key Points

To describe the rationale and design of the CONVERGE trial evaluating whether a hybrid epicardial and endocardial ablation strategy improves outcomes compared with standard endocardial catheter ablation in patients with persistent atrial fibrillation.
Conducted a prospective, multicenter, open-label, 2:1 randomized controlled pivotal trial enrolling 153 patients across 27 centers with symptomatic persistent atrial fibrillation refractory or intolerant to class I or III antiarrhythmic drugs.
Randomized participants to either the Convergent hybrid procedure (minimally invasive pericardioscopic epicardial ablation combined with endocardial ablation) or standard endocardial catheter ablation alone.
Permitted inclusion of patients with longstanding persistent atrial fibrillation and left atrial diameters up to 6 cm without restriction on diagnosed arrhythmia duration.
The primary effectiveness endpoint is defined as freedom from atrial fibrillation, atrial flutter, or atrial tachycardia off new class I or III antiarrhythmic drugs between 3 and 12 months post-procedure.
The primary safety endpoint evaluates the cumulative incidence of major adverse events occurring from the index procedure through 30 days of follow-up.

Study Design

Type

RCT (n=153)

Blinding

Open-label

Randomization

2:1

Multicenter

Yes

Structured PICO

Does the Convergent hybrid procedure improve freedom from atrial arrhythmias compared to endocardial catheter ablation in patients with symptomatic persistent AF?

Population

153 patients with symptomatic persistent atrial fibrillation refractory to anti-arrhythmic drugs, randomized 2:1 to a hybrid procedure or catheter ablation, followed for 12 months.

Intervention

Convergent hybrid procedure (combination of minimally invasive pericardioscopic epicardial ablation with endocardial left atrial ablation)

Comparator

Endocardial catheter ablation

Outcome

Freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-monthscomposite

The CONVERGE trial is designed to evaluate whether a hybrid epicardial and endocardial ablation approach improves arrhythmia-free survival compared to endocardial ablation alone in patients with persistent and long-standing persistent AF.

Cite This Study

DeLurgio et al. (2020) conducted an RCT in Symptomatic persistent atrial fibrillation (n=153). Convergent hybrid procedure (epicardial and endocardial ablation) vs. Endocardial catheter ablation was evaluated on Freedom from AF/AFL/AF absent class I/III AAD, except for a previously failed class I/ III AAD with no increase in dosage following 3-months through 12-months. The CONVERGE trial is a randomized study designed to evaluate the Convergent hybrid procedure versus endocardial catheter ablation in 153 patients with symptomatic persistent atrial fibrillation.

synapsesocial.com/papers/6a71bd36439bab0cabc3a93e https://doi.org/10.1016/j.ahj.2020.02.016

Topics

Persistent AF management Atrial fibrillation AF ablation outcomes Anticoagulation in AF

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Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

Topics

Convergence of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Persistent AF (CONVERGE Trial): Rationale and design

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Cite This Study

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Topics

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