Clinical trial NCT05411614: Hybrid AbLaTion of Atrial Fibrillation
Official title: A Randomised Controlled Trial Comparing Hybrid Convergent Ablation to Standard Catheter Ablation in Patients With Non-Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Atrial Fibrillation, Persistent
Atrial Arrhythmia
Atrial Fibrillation
Lead sponsor: St. George's Hospital, London
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical study. 1:1 randomised. Convergent Hybrid Ablation Procedure versus standalone endocardial catheter ablation).
Primary purpose: TREATMENT

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)

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.

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).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Persistent or Long-standing Persistent AF
* Dilated left atrium
* Suitable for either procedure

Exclusion Criteria:

* 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 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, breast-feeding, 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

Primary outcomes:
measure: Freedom from persistent atrial arrhythmia after a single procedure (either the completed hybrid ablation or catheter ablation) off Class I or III medications
timeFrame: Measured from the end of a 3-month blanking period at 12 and 24 months
Secondary outcomes:
measure: Safety Endpoint
timeFrame: Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure
measure: Freedom from any atrial arrhythmia lasting > 30 seconds after a single completed procedure on class I/III medications
timeFrame: Measured from the end of a 3- month blanking period at 12 and 24 months
measure: Freedom from atrial arrhythmias after any redo procedures (on or off class I or III medications)
timeFrame: Measured from the end of a 3- month blanking period at 12 and 24 months
measure: To assess left ventricular structural remodelling and change in ventricular function in response to either procedure
timeFrame: Pre-procedure and at 12 and 24 months post-procedure
measure: To assess left atrial remodelling in response to either technique.
timeFrame: Pre-procedure andat 12 and 24 months post-procedure
measure: To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)
timeFrame: Pre-procedure and at 12 and 24 months post-procedure
measure: To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).
timeFrame: Pre-procedure and at 12 and 24 months post-procedure
measure: To evaluate the effects of the interventions on the patient's quality of life (EQ5D)
timeFrame: Pre-procedure and at 12 and 24 months post-procedure
measure: To evaluate the effects of the interventions on the patient's quality of life (AFEQT)
timeFrame: Pre-procedure and at 12 and 24 months post-procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Georges University of London
Study officials:
affiliation: St Georges Hospital NHS Trust
name: Riyaz A Kaba
role: PRINCIPAL_INVESTIGATOR
affiliation: St Georges Hospital NHS Trust
name: Omar Ahmed
role: PRINCIPAL_INVESTIGATOR
References: