At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. (device), Standard Endocardial Catheter Ablation (procedure)
- How long the study runs
- Study runs about 27 months (dates as stated)
- About the drug or intervention
- Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. — device: 2 stage procedure - minimally-invasive epicardial ablation with left atrial appendage exclusion using LARIAT procedure via a subxiphoid incision. · Standard Endocardial Catheter Ablation — procedure: Standard percutaneous endocardial catheter ablation of atrial fibrillation
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 48
- Started
- 2024-08-02
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for persistent atrial fibrillation
- • NA - 48 participants
- • A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF)
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with persistent atrial fibrillation
Where?
- • London - St Bartholomew's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).
More detail
Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure. If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use. The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions. Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation. This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Age \> 18 years; \< 80 years
- ✓Persistent AF \> 1-year duration
- ✓Left atrium size \< 6cm
- ✓Pts should be able to provide written agreement to take part.
Who cannot take part
- ✗Subjects currently enrolled in another investigational study except in case of observational registry with no...
- ✗Subject has a reversible cause of AF or transient AF
- ✗Subject is absent of LAA or if the LAA is previously surgically ligated
- ✗Subject has had previous heart surgery or abdominal surgery.
- ✗Subject has safety concern to anticoagulation.
See the full criteria
Where Is This Study? (1 UK site)
St Bartholomew's Hospital
London EC1A 4AS, United Kingdom
How to Get in Touch
Syed Ahsan
Sponsor contactCONTACT
Shahana Hussain
Sponsor contactCONTACT
