Hybrid AbLaTion of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— HALT-AF  

Official title:

A Randomised Controlled Trial Comparing Hybrid Convergent Ablation to Standard Catheter Ablation in Patients With Non-Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411614
• Other study ID #: 2021.0137
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 2027

Study information

• Verified date: November 2023
• Source: St. George's Hospital, London
• Contact: Riyaz A Kaba
• Phone: 020 8725 4571
• Email: rkaba[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Persistent Atrial Fibrillation

Intervention

Device:
• 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
• Endocardial Catheter Ablation
Standard percutaneous endocardial catheter ablation of atrial fibrillation

Locations

Country	Name	City	State
United Kingdom	St Georges University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
St. George's Hospital, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Measured from the end of a 3-month blanking period at 12 and 24 months
Secondary	Safety Endpoint	Safety endpoint of severe and non-severe complications as defined in the protocol	Measured as early (within 30- days) and late (> 30 days) after each procedure or part of procedure
Secondary	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	Measured from the end of a 3- month blanking period at 12 and 24 months
Secondary	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	Measured from the end of a 3- month blanking period at 12 and 24 months
Secondary	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)	Pre-procedure and at 12 and 24 months post-procedure
Secondary	To assess left atrial remodelling in response to either technique.	Left atrial size on Echocardiography	Pre-procedure andat 12 and 24 months post-procedure
Secondary	To evaluate the effects of the interventions on the patient's symptoms and quality of life (EHRA Score)	Change in European Heart Rhythm Association (EHRA) AF Symptom score	Pre-procedure and at 12 and 24 months post-procedure
Secondary	To evaluate the effects of the interventions on the patient's symptoms and quality of life (NYHA Class).	Change in New York Heart Association (NYHA) class	Pre-procedure and at 12 and 24 months post-procedure
Secondary	To evaluate the effects of the interventions on the patient's quality of life (EQ5D)	Change in EuroQol Quality of life Score (EQ5D)	Pre-procedure and at 12 and 24 months post-procedure
Secondary	To evaluate the effects of the interventions on the patient's quality of life (AFEQT)	Change in Atrial Fibrillation Effect on Quality of Life Score (AFEQT)	Pre-procedure and at 12 and 24 months post-procedure