Persistent Atrial FibrillationCLIP-AFNCT06165510
Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
A study testing Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. and Standard Endocardial Catheter Ablation in people with Persistent Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrium; Fibrillation
- What is being tested?
- Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. and Standard Endocardial Catheter Ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years; < 80 years
- Persistent AF > 1-year duration
- Left atrium size < 6cm
- Pts should be able to provide written informed consent.
Who cannot join
- Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
- 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 cardiac surgery or abdominal surgery.
- Subject has contraindication to anticoagulation.
- Patients with hypertrophic cardiomyopathy.
- Patients with significant valve disease.
- Subject has had previous catheter or surgical ablation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London, EC1A 4AS
Syed Ahsan, 020 7377 7000, syedahsan@nhs.net
Syed Ahsan
About this study
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).
Read the detailed description
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.
- Conditions
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrium; Fibrillation, Atrial Arrhythmia
- Being tested
- Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device., Standard Endocardial Catheter Ablation
- Keywords
- Catheter ablation, Convergent procedure, Left atrial appendage, Hybrid ablation, Cardiac arrhythmias
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. This is then combined with endocardial radiofrequency catheter ablation in a separate staged procedure.
Standard Endocardial Catheter AblationProcedure or surgery
Standard percutaneous endocardial catheter ablation of atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Convergent AF Ablation with Left Atrial Appendage Exclusion | Experimental | Two Staged Convergent AF Ablation Procedure
Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure)
Stage 2 - Percutaneous Endocardial Catheter Ablation Receives: Device: Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.; Procedure: Standard Endocardial Catheter Ablation |
| Standard Endocardial Catheter Ablation | Active comparator | Standard Endocardial Catheter Ablation Receives: Procedure: Standard Endocardial Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate trial feasibility with regards to recruitment rate
Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured.
Measured: 24 months
A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis > 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention.
Measured: 30 days post procedure
Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds)
Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications
Measured: Measured from the end of a 3 month blanking period to 12 months post procedure
Measure improvement in symptoms following convergent ablation
Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity.
Measured: 12 months
Secondary outcomes (3)
Measure improvement in symptoms following convergent ablation.
To measure improvement in quality of life assessment measured through the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire) to be performed at baseline, 6 months and 12 months post procedure. This survey employs the use of 20 questions regarding symptoms, effect on daily activities, treatment concerns and treatment satisfaction to generate a score from 0 - 100. The lower the score, the more severe the disability with score 0 indicating complete disability and score 100 indicating no disability or limitation in daily activities.
Measured: 12 months
Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.
Assessment of LVEF via transthoracic echocardiogram at baseline and transthoracic echocardiogram at 12 months post procedure.
Measured: 12 months
Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.
Assessment of heart failure symptoms and functional status via clinic review at baseline and 12 months post-procedure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start2 Aug 2024
- Primary completion1 Nov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical study with 1:1 recruitment in each arm - Convergent AF Ablation with LARIAT procedure versus endocardial catheter ablation.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Sponsor
- Investigators
- Syed Ahsan, Principal investigator, Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165510
- Sponsor's protocol ID
- 320553
- Acronym
- CLIP-AF
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06165510
- Acronym / sponsor ID
- CLIP-AF / 320553
- Conditions
- Persistent Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrium; Fibrillation, Atrial Arrhythmia
- Keywords
- Catheter ablation, Convergent procedure, Left atrial appendage, Hybrid ablation, Cardiac arrhythmias
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical study with 1:1 recruitment in each arm - Convergent AF Ablation with LARIAT procedure versus endocardial catheter ablation.
| Arm | Type | Receives |
|---|---|---|
| Convergent AF Ablation with Left Atrial Appendage Exclusion | Experimental | Device: Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device., Procedure: Standard Endocardial Catheter AblationTwo Staged Convergent AF Ablation Procedure Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure) Stage 2 - Percutaneous Endocardial Catheter Ablation |
| Standard Endocardial Catheter Ablation | Active comparator | Procedure: Standard Endocardial Catheter AblationStandard Endocardial Catheter Ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years; < 80 years
- Persistent AF > 1-year duration
- Left atrium size < 6cm
- Pts should be able to provide written informed consent.
Key exclusion criteria (8 listed)
- Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
- 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 cardiac surgery or abdominal surgery.
- Subject has contraindication to anticoagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device.2 stage procedure - minimally-invasive epicardial ablation with left atrial appendage exclusion using LARIAT procedure via a subxiphoid incision. This is then combined with endocardial radiofrequency catheter ablation in a separate staged procedure. | Device | Convergent AF Ablation with Left Atrial Appendage Exclusion |
| Standard Endocardial Catheter AblationStandard percutaneous endocardial catheter ablation of atrial fibrillation | Procedure or surgery | Convergent AF Ablation with Left Atrial Appendage Exclusion, Standard Endocardial Catheter Ablation |
Primary outcome
Demonstrate trial feasibility with regards to recruitment rate
Time frame: 24 months
Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured.
A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
Time frame: 30 days post procedure
Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis > 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention.
Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds)
Time frame: Measured from the end of a 3 month blanking period to 12 months post procedure
Recurrence of any atrial arrhythmia > 30 seconds on or off class I / III medications
Measure improvement in symptoms following convergent ablation
Time frame: 12 months
Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity.
3 secondary outcomes
Measure improvement in symptoms following convergent ablation.
Time frame: 12 months
Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.
Time frame: 12 months
Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syed Ahsan principal investigator
Consultant Cardiologist and Electrophysiologist, Barts Health NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. and Standard Endocardial Catheter Ablation in people with Persistent Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Ahsan (020 7377 7000, syedahsan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate trial feasibility with regards to recruitment rate (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.