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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05411614
Other study ID # 2021.0137
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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