A Randomised Controlled Trial Comparing Convergent Hybrid Ablation to Catheter Ablation in Patients With Persistent Atrial Fibrillation and Heart Failure

St. George's Hospital, London7 sites in 1 country120 target enrollmentJune 25, 2022

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: St. George's Hospital, London
Enrollment: 120
Locations: 7
Primary Endpoint: Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

June 25, 2022

End Date

October 1, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

St. George's Hospital, London

Responsible Party

Principal Investigator

Riyaz Kaba

Consultant in Cardiology and Cardiac Electropysiology

St. George's Hospital, London

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

Safety Endpoint(Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure)
Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications(Measured from the end of a 3- month blanking period at 12 and 24 months)
Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)(Measured from the end of a 3- month blanking period at 12 and 24 months)
To assess left ventricular structural remodelling and change in ventricular function in response to either procedure(Pre-procedure and at 12 and 24 months post-procedure)
To assess left atrial remodelling in response to either technique.(Pre-procedure and up to 12 and 24 months post-procedure)
To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)(Pre-procedure and at 12 and 24 months post-procedure)
To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).(Pre-procedure and at 12 and 24 months post-procedure)
To evaluate the effects of the interventions on the patient's quality of life (EQ5D)(Pre-procedure and at 12 and 24 months post-procedure)
To evaluate the effects of the interventions on the patient's quality of life (AFEQT)(Pre-procedure and at 12 and 24 months post-procedure)