Hybrid Ablation of Atrial Fibrillation in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-25

Study Completion Date

2027-10-31

Brief Summary

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A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF) and Heart Failure

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Detailed Description

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The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF and heart failure.

Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Conditions

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Persistent Atrial Fibrillation Atrial Fibrillation, Persistent Atrial Arrhythmia Atrial Fibrillation Heart Failure Left Ventricular (LV) Systolic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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AtriCure EPi-Sense-AF Guided Coagulation System +/- Atriclip

Minimally-invasive epicardial ablation +/- left atrial appendage exclusion using an epicardial clip, combined with endocardial radiofrequency catheter ablation

Intervention Type DEVICE

Endocardial Catheter Ablation

Standard percutaneous endocardial catheter ablation of atrial fibrillation

Intervention Type DEVICE

Other Intervention Names

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Convergent Hybrid Epicardial Endocardial Ablation plus/minus left atrial appendage exclusion Percutaneous Catheter Ablation

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Persistent or Long-standing Persistent AF
* Dilated left atrium (at least moderately dilated)
* Suitable for either procedure
* LVEF \< 50%

Exclusion Criteria

* Not yet optimised from a medical or lifestyle perspective for AF or heart failure
* Unable to provide written consent
* Previous open-heart surgery
* Active infection, oesophageal ulcer stricture or oesophageal varices
* Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
* Contraindication to anticoagulation, or active thrombus in the left atrium despite therapeutic anticoagulation
* Severe valvular heart disease
* Unstable coronary artery disease
* Uncontrolled ventricular arrhythmia
* Heart attack or stroke within the last 90 days
* Pregnant, breastfeeding, or women of childbearing age who plan to get pregnant within six months
* Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No