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
- Conduction system pacing (device), Atrioventricular nodal ablation (procedure), Atrial fibrillation ablation (procedure)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- Conduction system pacing — device: Conduction system pacing (either His bundle pacing or left bundle branch area pacing) · Atrioventricular nodal ablation — procedure: Catheter ablation of the atrioventricular node · Atrial fibrillation ablation — procedure: Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at two treatments for people with persistent atrial fibrillation (an irregular heart rhythm that does not stop on its own) and heart failure. It compares ablation to treat the atrial fibrillation itself against ablation of the atrioventricular node (the heart's electrical 'junction') combined with conduction system pacing, where a device helps control the heartbeat.
Who can take part
- Persistent atrial fibrillation with symptoms of heart failure despite medication, and considered suitable for atrial fibrillation ablation, with no more than one previous pulmonary vein isolation procedure
- At least one hospital admission, emergency room visit, or heart failure clinic visit in the past 2 years, with high levels of certain heart blood tests (NT-pro-BNP over 1000 pg/ml or BNP over 250 pg/ml)
- Previous or current treatment with rate or rhythm control medicines
- Age over 60 years
Who may not be able to
- Severe heart failure (NYHA Class IV) with systolic blood pressure of 80 mmHg or below despite the best treatment
- Life expectancy of less than 2 years
- Need for major surgery
- Heart attack, stroke, or a procedure to open heart arteries (PCI) in the past 3 months
- A pacemaker or CRT (cardiac resynchronisation therapy) device already fitted or planned (an ICD, a device that shocks dangerous rhythms, without a pacing need is acceptable)
- Taking part in another controlled trial
- Unable to give informed consent
What taking part involves
- • Being placed into one of two groups: atrial fibrillation ablation, or atrioventricular node ablation combined with conduction system pacing
- • Further details of the procedures and follow-up — Not stated — ask the trial team
Time commitment: Not stated — ask the trial team (number of visits and how long the study lasts are not given in the registry record).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 60 Years and over
- Who
- All
- Number of participants
- 220
- Started
- 2024-10-01
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation, persistent
- • NA - 220 participants
- • The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation
Who can take part?
- • Ages 60 Years and over
- • Diagnosed with atrial fibrillation, persistent
Where?
- • London - National Heart and Lung Institute, Imperial College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.
More detail
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients. Hypotheses 1. CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization. 2. CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization. Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in \~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation. Sample size 220 patients Study duration 4 years
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: 60 Years and over
- Who can join: All genders
What the study is looking for
- ✓(i) Persistent AF with causing symptoms HF despite medical therapy, considered to be suitable for AF ablation, with at...
- ✓(iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years
Who cannot take part
- ✗(i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.
- ✗(vi) Participation in another controlled trial. (vii) Inability to sign and agreement to take part form.
See the full criteria
Where Is This Study? (1 UK site)
National Heart and Lung Institute, Imperial College London
London, United Kingdom
How to Get in Touch
Haran Burri
Sponsor contactCONTACT
Nikola Kozhuharov
Sponsor contactCONTACT