Atrial FibrillationLAUDABLENCT04111731
Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation
A study testing Cryoballoon pulmonary vein isolation, Radiofrequency pulmonary vein isolation and Repeat electrophysiological study in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonary veins (PVs) at the back of the heart which connect it to the lungs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Cryoballoon pulmonary vein isolation, Radiofrequency pulmonary vein isolation and Repeat electrophysiological study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Mar 2020to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years
- Evidence of persistent Atrial Fibrillation
Who cannot join
- Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
- An indwelling atrial septal defect (ASD) occluder device or anatomical structure that pre-vents free access to the left atrium
- Left atrial diameter on transthoracic echo (Parasternal long axis, M-mode) > 5.5cm
- Recent stroke/Transient Ischaemic Attack within 3 months
- Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
- Severe kidney impairment (estimated Glomerular Filtration Rate < 30ml/min)
Show all 10Show fewer
- Morbid obesity (Body Mass Index ≥40)
- Extreme frailty
- Severe valvular heart disease of any kind as assessed by the investigator, with or without prosthetic valve in place
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
Manchester University NHS Foundation Trust
Manchester, M13 9WL
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: Left Atrial Arrhythmia Substrate Identification by Ultra-high Density Mapping After Confirmed durABLE Pulmonary Vein Isolation
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonary veins (PVs) at the back of the heart which connect it to the lungs. These PVs have been identified to serve as the sites where the abnormal heart rhythm is generated. One of the treatments is called radiofrequency (RF) catheter ablation, where 'heat energy' is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 PVs at their bases. The other treatment technique utilises a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 PVs to achieve the electrical isolation. Sometimes the treated tissues develop reconnections that can lead to a recurrence of the abnormal heart rhythm, and thus the need for a repeat procedure.
In this study, participants will receive a second treatment 2 months after the first one. During the second treatment, investigators will check to identify areas that have developed reconnections since the first treatment; these will be treated again. This will increase the chances of all participants having a complete treatment.
In order to improve understanding of how best to treat this condition, investigators will also carry out some further measurements within the heart during the repeat procedure. During these measurements, investigators will check to see if treatment has succeeded in reducing the occurrence of an abnormal heart rhythm. In the group of participants in whom RF energy is used for the initial procedure, investigators will also treat the back wall of the heart, and repeat these measurements.
Read the detailed description
Persistent atrial fibrillation (PeAF) is defined as continuous atrial fibrillation for 7 days or more. Approximately 10% of people are diagnosed with atrial fibrillation (AF) by age 80 years; and among people of European descent, 26% of men and 23% of women have a lifetime risk of developing AF after age 40.
Catheter ablation by pulmonary vein isolation is the usual approach employed for PeAF. This involves making lesions within the pulmonary veins to achieve electrical isolation. Electrical isolation cuts off abnormal electrical triggers originating from the pulmonary veins. However, treatment outcomes are less than optimal with a lot of variability in success rates for different techniques. Hence, the optimal treatment strategy for patients with PeAF is not clear.
In this pilot study, investigators aim to study two different treatment modalities of catheter ablation: cold balloon (cryoballoon, Group 1) and hot tip (radiofrequency ablation, Group 2) used in (electrically) isolating the pulmonary veins. There will be 1:1 randomisation to either of the two modalities. All participants will subsequently undergo a repeat procedure 2 months later to identify reconnections and to re-isolate the veins using the hot tip (radiofrequency ablation) guided by an ultra-high density mapping technology. During the repeat procedure, investigators will perform further electrophysiological studies including assessing arrhythmia inducibility and measuring the extent of isolated areas. For participants in Group 2, investigators will also make some lesions in the back wall of the heart (posterior wall isolation) and recheck arrhythmia inducibility.
All participants will be given a handheld ECG recording (Omron) device. Participants will be shown how to use the device to make daily 30-second recordings and when they have symptoms, to be reviewed. Follow up will be at 3, 6 and 12 months.
- Being tested
- Cryoballoon pulmonary vein isolation, Radiofrequency pulmonary vein isolation, Repeat electrophysiological study, Left atrial posterior wall isolation
- Keywords
- Radiofrequency catheter ablation, Cryoballoon pulmonary vein isolation, Rhythmia, Orion catheter, Posterior wall isolation, Electrophysiological study, Omron device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon pulmonary vein isolationProcedure or surgery
Catheter ablation using cryoballoon pulmonary vein isolation. Utilisation of a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 pulmonary veins to achieve electrical isolation.
Radiofrequency pulmonary vein isolationProcedure or surgery
Catheter ablation using radiofrequency energy to achieve pulmonary vein isolation. Radiofrequency energy is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 pulmonary veins at their bases
Repeat electrophysiological studyProcedure or surgery
Also called Repeat catheter ablation
All participants will receive a repeat electrophysiological study 2 months after the index procedure during which radiofrequency catheter ablation guided by ultra-high density mapping will be used to identify regions of reconnection that need re-isolation; other tests will be carried out including testing for arrhythmia inducibility
Left atrial posterior wall isolationProcedure or surgery
Also called Posterior wall isolation
The left atrial posterior wall will be isolated in Group 2 participants (those who received radiofrequency ablation at the index procedure) during the repeat electrophysiological study in 2 months
| Study group | Role | What they receive |
|---|---|---|
| Group one | Active comparator | Cryoballoon pulmonary vein isolation Receives: Procedure: Cryoballoon pulmonary vein isolation; Procedure: Repeat electrophysiological study |
| Group two | Active comparator | Radiofrequency pulmonary vein isolation Receives: Procedure: Radiofrequency pulmonary vein isolation; Procedure: Repeat electrophysiological study; Procedure: Left atrial posterior wall isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of late pulmonary vein re-connections
Number of late pulmonary vein re-connections at repeat electrophysiological study as identified by ultra-high density mapping: comparison between the 80 pulmonary veins in each group
Measured: Up to 2 months after index ablation procedure
Secondary outcomes (9)
Amount of radiofrequency energy needed to re-isolate the veins
Amount of radiofrequency energy needed at repeat electrophysiological study to re-isolate the pulmonary veins
Measured: 2 months after the index ablation procedure
Area of low voltage
Area of left atrial low voltage at start of repeat electrophysiological study under ultra-high density mapping guidance in each group
Measured: 2 months after the index ablation procedure
Incidence of arrhythmia inducibility before and after left atrial posterior wall isolation
Incidence of arrhythmia inducibility after complete posterior wall isolation as compared to after pulmonary vein isolation alone assessed during an electrophysiological study
Measured: 2 months after the index ablation procedure
Incidence of peri-procedural complications
Incidence of peri-procedural complications such as tamponade, major bleeding, myocardial infarction, requirement for permanent pacemaker, stroke, death
Measured: From index procedure to after repeat procedure
Incidence of renal function impacting on left atrial electrical properties
Incidence of renal function impacting on electrical properties of the left atrium and arrhythmic substrate: assessed at baseline and during repeat electrophysiological study
Measured: At the index procedure and 2 months after the index procedure
Total length of time free from atrial arrhythmia estimated with the Omron device
Freedom from atrial arrhythmia at 12 months following the 2 procedures: comparison between groups. Time period free from atrial arrhythmia in minutes/hours/days
Measured: At the 12th month follow-up visit
Quality of life assessment: validated questionnaire
At baseline, 6 months and at 12 months using a validated questionnaire with 2 components: descriptive system and visual analogue scale. Descriptive system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels: no problems (level 1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). The digits for the 5 dimensions will be combined into a 5-digit number describing the participant's health state - a total of 3125 possible health states. The health state will be converted to a single index value using conversion tables, and summarised as means or medians. Visual analogue scale records the participant's self-rated health on a 20 cm vertical scale with endpoints 'the best health you can imagine' and 'the worst health you can imagine'. It will be summarised as means or medians.
Measured: At the index procedure and at the 6th month and 12th month follow-up appointments
Clot formation and fibrinolysis assessment using turbidimetric analyses
Clot formation (lag time, rate of clot formation, maximum absorbance) and rate of fibrinolysis
Measured: At baseline, 2 months and 12 months
Fibrin permeation testing
Permeation constant (Ks)
Measured: At baseline, 2 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Mar 2020
- Primary completion11 Mar 2024
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- A randomised, controlled multi-centre pilot study. Forty participants with persistent atrial fibrillation will have an equal chance of being randomised to receive either of two treatment techniques of pulmonary vein isolation: Cryoballoon (Group 1) or Radiofrequency ablation (Group 2). Subsequently, all patients will undergo a repeat procedure 2 months later to assess for reconnections requiring further treatment. In Group 2 participants, there will also be lesions made to the back wall of the heart (left atrial posterior wall isolation).
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Dhiraj Gupta, MBBS MD FRCP, Study chair, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111731
- Sponsor's protocol ID
- 1200
- Acronym
- LAUDABLE
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Arrhythmia Substrate Identification by Ultra-high Density Mapping After Confirmed durABLE Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT04111731
- Acronym / sponsor ID
- LAUDABLE / 1200
- Keywords
- Radiofrequency catheter ablation, Cryoballoon pulmonary vein isolation, Rhythmia, Orion catheter, Posterior wall isolation, Electrophysiological study, Omron device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 1 Oct 2019 (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.
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonary veins (PVs) at the back of the heart which connect it to the lungs. These PVs have been identified to serve as the sites where the abnormal heart rhythm is generated. One of the treatments is called radiofrequency (RF) catheter ablation, where 'heat energy' is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 PVs at their bases. The other treatment technique utilises a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 PVs to achieve the electrical isolation. Sometimes the treated tissues develop reconnections that can lead to a recurrence of the abnormal heart rhythm, and thus the need for a repeat procedure.
In this study, participants will receive a second treatment 2 months after the first one. During the second treatment, investigators will check to identify areas that have developed reconnections since the first treatment; these will be treated again. This will increase the chances of all participants having a complete treatment.
In order to improve understanding of how best to treat this condition, investigators will also carry out some further measurements within the heart during the repeat procedure. During these measurements, investigators will check to see if treatment has succeeded in reducing the occurrence of an abnormal heart rhythm. In the group of participants in whom RF energy is used for the initial procedure, investigators will also treat the back wall of the heart, and repeat these measurements.
Detailed description
Persistent atrial fibrillation (PeAF) is defined as continuous atrial fibrillation for 7 days or more. Approximately 10% of people are diagnosed with atrial fibrillation (AF) by age 80 years; and among people of European descent, 26% of men and 23% of women have a lifetime risk of developing AF after age 40.
Catheter ablation by pulmonary vein isolation is the usual approach employed for PeAF. This involves making lesions within the pulmonary veins to achieve electrical isolation. Electrical isolation cuts off abnormal electrical triggers originating from the pulmonary veins. However, treatment outcomes are less than optimal with a lot of variability in success rates for different techniques. Hence, the optimal treatment strategy for patients with PeAF is not clear.
In this pilot study, investigators aim to study two different treatment modalities of catheter ablation: cold balloon (cryoballoon, Group 1) and hot tip (radiofrequency ablation, Group 2) used in (electrically) isolating the pulmonary veins. There will be 1:1 randomisation to either of the two modalities. All participants will subsequently undergo a repeat procedure 2 months later to identify reconnections and to re-isolate the veins using the hot tip (radiofrequency ablation) guided by an ultra-high density mapping technology. During the repeat procedure, investigators will perform further electrophysiological studies including assessing arrhythmia inducibility and measuring the extent of isolated areas. For participants in Group 2, investigators will also make some lesions in the back wall of the heart (posterior wall isolation) and recheck arrhythmia inducibility.
All participants will be given a handheld ECG recording (Omron) device. Participants will be shown how to use the device to make daily 30-second recordings and when they have symptoms, to be reviewed. Follow up will be at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised, controlled multi-centre pilot study. Forty participants with persistent atrial fibrillation will have an equal chance of being randomised to receive either of two treatment techniques of pulmonary vein isolation: Cryoballoon (Group 1) or Radiofrequency ablation (Group 2). Subsequently, all patients will undergo a repeat procedure 2 months later to assess for reconnections requiring further treatment. In Group 2 participants, there will also be lesions made to the back wall of the heart (left atrial posterior wall isolation).
| Arm | Type | Receives |
|---|---|---|
| Group one | Active comparator | Procedure: Cryoballoon pulmonary vein isolation, Procedure: Repeat electrophysiological studyCryoballoon pulmonary vein isolation |
| Group two | Active comparator | Procedure: Radiofrequency pulmonary vein isolation, Procedure: Repeat electrophysiological study, Procedure: Left atrial posterior wall isolationRadiofrequency pulmonary vein isolation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 80 years
- Evidence of persistent Atrial Fibrillation
Key exclusion criteria (10 listed)
- Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
- An indwelling atrial septal defect (ASD) occluder device or anatomical structure that pre-vents free access to the left atrium
- Left atrial diameter on transthoracic echo (Parasternal long axis, M-mode) > 5.5cm
- Recent stroke/Transient Ischaemic Attack within 3 months
- Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
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 |
|---|---|---|
| Cryoballoon pulmonary vein isolationCatheter ablation using cryoballoon pulmonary vein isolation. Utilisation of a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 pulmonary veins to achieve electrical isolation. | Procedure or surgery | Group one |
| Radiofrequency pulmonary vein isolationCatheter ablation using radiofrequency energy to achieve pulmonary vein isolation. Radiofrequency energy is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 pulmonary veins at their bases | Procedure or surgery | Group two |
| Repeat electrophysiological studyAlso: Repeat catheter ablationAll participants will receive a repeat electrophysiological study 2 months after the index procedure during which radiofrequency catheter ablation guided by ultra-high density mapping will be used to identify regions of reconnection that need re-isolation; other tests will be carried out including testing for arrhythmia inducibility | Procedure or surgery | Group one, Group two |
| Left atrial posterior wall isolationAlso: Posterior wall isolationThe left atrial posterior wall will be isolated in Group 2 participants (those who received radiofrequency ablation at the index procedure) during the repeat electrophysiological study in 2 months | Procedure or surgery | Group two |
Primary outcome
Number of late pulmonary vein re-connections
Time frame: Up to 2 months after index ablation procedure
Number of late pulmonary vein re-connections at repeat electrophysiological study as identified by ultra-high density mapping: comparison between the 80 pulmonary veins in each group
9 secondary outcomes
Amount of radiofrequency energy needed to re-isolate the veins
Time frame: 2 months after the index ablation procedure
Area of low voltage
Time frame: 2 months after the index ablation procedure
Incidence of arrhythmia inducibility before and after left atrial posterior wall isolation
Time frame: 2 months after the index ablation procedure
Incidence of peri-procedural complications
Time frame: From index procedure to after repeat procedure
Incidence of renal function impacting on left atrial electrical properties
Time frame: At the index procedure and 2 months after the index procedure
Total length of time free from atrial arrhythmia estimated with the Omron device
Time frame: At the 12th month follow-up visit
Quality of life assessment: validated questionnaire
Time frame: At the index procedure and at the 6th month and 12th month follow-up appointments
Clot formation and fibrinolysis assessment using turbidimetric analyses
Time frame: At baseline, 2 months and 12 months
Fibrin permeation testing
Time frame: At baseline, 2 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Dhiraj Gupta, MBBS MD FRCP study chair
Liverpool Heart and Chest Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon pulmonary vein isolation, Radiofrequency pulmonary vein isolation and Repeat electrophysiological study in people with Atrial Fibrillation and Persistent Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 3 sites 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of late pulmonary vein re-connections (time frame: Up to 2 months after index ablation procedure). 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 27 Mar 2026.