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Hybrid Ablation of Atrial Fibrillation in Heart Failure

ConditionsPersistent Atrial FibrillationAtrial Fibrillation, PersistentAtrial ArrhythmiaAtrial FibrillationHeart FailureLeft Ventricular (LV) Systolic Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. George's Hospital, London

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Persistent or Long-standing Persistent AF

Dilated left atrium (at least moderately dilated)

Suitable for either procedure

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

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

  • Endocardial Catheter Ablation

    Device

    Standard percutaneous endocardial catheter ablation of atrial fibrillation

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Convergent Hybrid Ablation +/- Left Atrial Appendage ExclusionExperimental treatment 2 interventions
Group B: Standard Endocardial Catheter AblationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications

Recurrence of persistent atrial arrhythmia during follow-up months).

Time frame
Measured from the end of a 3-month blanking period at 12 and 24 months

Secondary outcomes

1

Safety Endpoint

Safety endpoint of severe and non-severe complications as defined in the protocol

Time frame
Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure
2

Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications

Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures

Time frame
Measured from the end of a 3- month blanking period at 12 and 24 months
3

Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)

Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications, considering any repeat ablation procedures

Time frame
Measured from the end of a 3- month blanking period at 12 and 24 months
4

To assess left ventricular structural remodelling and change in ventricular function in response to either procedure

Left ventricular ejection fraction as recorded on transthoracic echocardiography (TTE)

Time frame
Pre-procedure and at 12 and 24 months post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. George's Hospital, London

Lead sponsor

Source ClinicalTrials.gov
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