Long Standing Persistent Atrial FibrillationLoTO_CASA_AFNCT04280042
Long-term Outcomes in Long Standing Persistent Atrial Fibrillation
An observational study of Long Standing Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a condition detected as an irregular heartbeat. It is the most common rhythm disturbance worldwide which can lead to significant symptoms and serious health problems (stroke and heart failure). The longer a person has AF, the more difficult it is to restore a normal heart rhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Standing Persistent Atrial Fibrillation
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2020to 1 Feb 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with long standing persistent atrial fibrillation who took part in the CASA AF clinical trial and underwent one of the intervetions: catheter ablation or surgical thoracoscopic ablation. These patients have agreed to keep their implanted loop recorders and continued to dowload their data.
Who may be able to join
- CASA-AF RCT participants who have undergone ablative procedure to treat their LSPAF, completed 12 months follow up and consented to keep their implanted loop recorders in situ with weekly data downloads.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes in Long Standing Persistent Atrial Fibrillation Following Catheter Or Thoracoscopic Surgical Ablation : Extended Follow-Up Of CASA-AF Randomised Controlled Trial
Atrial fibrillation (AF) is a condition detected as an irregular heartbeat. It is the most common rhythm disturbance worldwide which can lead to significant symptoms and serious health problems (stroke and heart failure). The longer a person has AF, the more difficult it is to restore a normal heart rhythm. Those with continuous AF for longer than a year are described as having longstanding persistent AF (LSPAF). This is the most challenging type of AF to treat and medications are often not effective. Apart from medications patients with LSPAF may be offered a medical procedure to help improve their symptoms. It involves putting a flexible thin tube (catheter) into a blood vessel in the groin and up into the heart to destroy the tissue causing irregular heart beat. This procedure has modest success in improving symptoms in the long term. Recently, keyhole surgery has been used for these patients and evidence shows that it is better than the catheter procedure. However, we do not know how well people are doing beyond one year. Feedback from a patient focus group suggested that knowing the long-term results of these two procedures is important to help them make an informed choice when it comes to treatment. In this study we propose to continue monitoring patients from a randomised clinical trial (CASA AF RCT) who have already had one of the procedures. They have a small heartbeat monitor implanted under the skin with a battery life of around 3 years. We will be able to look at their heart rhythm data for the duration of this period and detect the return of the fibrillation if it happens.
Read the detailed description
This study involves participants from the randomised clinical trial which was just completed (CASA AF RCT: NCT02755688; ISRCTN18250790 ). They have undergone relevant ablation procedures in a randomised fashion and completed 12 months follow up. At the last study visit they signed a consent form to confirm that they have agreed to keep implanted loop recorder for the duration of its battery life time (approximately 3 years). They have also continued to regularly transfer data from their implanted loop recorder to the secure server where it is regularly reviewed. This group of patients is now a unique cohort whose follow up data is invaluable for additional research. For this study we will ask for their written consent and apart from analysing their heart rhythm data we will arrange two hospital visits with some additional tests and completion of questionnaires.
The principal objective of the study is to compare the long-term effectiveness of thoracoscopic surgical ablation and percutaneous catheter ablation, the two procedures available for treatment of atrial fibrillation in patients with longstanding persistent AF (LSPAF). There is some evidence that thoracoscopic surgical ablation may be better than catheter ablation in keeping the patients in regular heart rhythm after a single procedure without use of antiarrhythmic drugs in short term. In this study we plan to monitor patients who have undergone these procedures for 3 years.
Our secondary objectives are focussing on patients who had more than one procedure and/or may be using medications in order to maintain regular heart rhythm during 36 months follow up.
We will therefore look at:
- the effectiveness of a single procedure (catheter or surgical) in maintaining normal rhythm with use of antiarrhythmic drugs.
- the effectiveness of multiple ablative procedures in maintaining sinus rhythm with and without use of antiarrhythmic drugs.
- the proportion of patients who are still in AF but the time they spend in it is reduced by ≥75%. We will also want to examine:
- patient reported change in quality of life from baseline to 24 and 36 months after ablative treatment.
- changes in levels of serum biomarkers from baseline to 36 months and how they relate to the freedom of arrhythmia
- health and social care resource use and associated costs from baseline to 36 months
- the cost-effectiveness of thoracoscopic surgical ablation compared with catheter ablation and update the health economic model developed for the main study (CASA AF RCT).
Our sample size calculations show that with an expected rate of attrition of around 20% we need 94-100 study participants to show the difference in the effectiveness of the two procedure with power of 80%, p= 0.05.
Patients participating in this extended follow-up study will attend two hospital appointments to coincide with 24 and 36 months post-ablation (± 6 months). These two visits will consist of:
- clinical examination
- review of concurrent medications and comorbidities
- electrocardiogram (12 lead ECG )
- blood test for routine biochemistry and collection of a sample for biomarkers analyses
- completion of questionnaires to assess patients' quality of life: atrial fibrillation effect on quality of life (AFEQT), EuroQol (EQ5D5L) European Heart Rhythm Association score of atrial fibrillation (EHRA),
- Health economic questionnaire to capture repeat procedures (ablation, direct current cardioversion and AF-related emergency care)
For the duration of the extended follow-up, once a week patients will download data from their implantable loop recorders which have algorithms that are specific for atrial arrhythmias (atrial fibrillation, atrial tachycardia, atrial flutter). Patients remotely download their data to the Medtronic (MyCarelinkTM) secure server. These data will be reviewed centrally every month by a dedicated Research Fellow. Patients will be contacted monthly by telephone to ensure compliance and to discuss any rhythm abnormalities detected in these data that require review of treatment/ management. Patients will be able to contact the research team if they experience symptoms of atrial arrhythmias. The implanted loop recorder data can be interrogated remotely, and appropriate advice regarding treatment given based on data review.
- Keywords
- atrial fibrillation, thoracoscopic surgical AF ablation, catheter ablation, implanted loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic surgical ablation | Participants in CASA AF Trial who underwent thoracoscopic surgical ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use. | |
| Cather ablation | Participants in CASA AF Trial who underwent conventional catheter ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a single ablative procedure
Freedom from continuous atrial arrhythmia (≥120 seconds in duration) recorded by implantable loop recorder or other clinically indicated rhythm recording device and absence of anti-arrhythmic drugs on concurrent medications form.
Measured: over the duration of the followup period (24 months)
Secondary outcomes (4)
Reduction of burden of atrial fibrillation
Proportion of patients who experience recurrence of atrial arrhythmias but are in sinus rhythm 75% of the time or more
Measured: over the duration of the followup period (24 months)
AF related quality of life
Measurement of changes in overall AFEQT scores (18 questions) and treatment satisfaction scores (2 questions) from baseline to two follow up time points
Measured: at 24 and 36 months from the ablative treatment
Quality of life assessment
EQ5D5L questionnaires (descriptive and analogue scale) will be completed at baseline and two follow up timepoints. Changes in scores on both scales will be used to assess and quantify patients' health outcome
Measured: at 24 and 36 months from the ablative treatment
Changes in concentration of serum biomarkers (pg/ml)
Serum assays for different biomarkers (pg/ml) will be performed at baseline and compared to the concentrations in samples collected at follow up visits. Increase (or decrease) of the biomarkers' concentration will be related to freedom from arrhythmia during follow up.
Measured: from baseline to 36 months after the ablative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Feb 2020
- Primary completion15 Nov 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Standing 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Tom Wong, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280042
- Sponsor's protocol ID
- 271930
- Acronym
- LoTO_CASA_AF
- Status last verified
- Apr 2022
- First submitted
- 18 Feb 2020
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes in Long Standing Persistent Atrial Fibrillation Following Catheter Or Thoracoscopic Surgical Ablation : Extended Follow-Up Of CASA-AF Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04280042
- Acronym / sponsor ID
- LoTO_CASA_AF / 271930
- Keywords
- atrial fibrillation, thoracoscopic surgical AF ablation, catheter ablation, implanted loop recorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 21 Feb 2020 (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.
Atrial fibrillation (AF) is a condition detected as an irregular heartbeat. It is the most common rhythm disturbance worldwide which can lead to significant symptoms and serious health problems (stroke and heart failure). The longer a person has AF, the more difficult it is to restore a normal heart rhythm. Those with continuous AF for longer than a year are described as having longstanding persistent AF (LSPAF). This is the most challenging type of AF to treat and medications are often not effective. Apart from medications patients with LSPAF may be offered a medical procedure to help improve their symptoms. It involves putting a flexible thin tube (catheter) into a blood vessel in the groin and up into the heart to destroy the tissue causing irregular heart beat. This procedure has modest success in improving symptoms in the long term. Recently, keyhole surgery has been used for these patients and evidence shows that it is better than the catheter procedure. However, we do not know how well people are doing beyond one year. Feedback from a patient focus group suggested that knowing the long-term results of these two procedures is important to help them make an informed choice when it comes to treatment. In this study we propose to continue monitoring patients from a randomised clinical trial (CASA AF RCT) who have already had one of the procedures. They have a small heartbeat monitor implanted under the skin with a battery life of around 3 years. We will be able to look at their heart rhythm data for the duration of this period and detect the return of the fibrillation if it happens.
Detailed description
This study involves participants from the randomised clinical trial which was just completed (CASA AF RCT: NCT02755688; ISRCTN18250790 ). They have undergone relevant ablation procedures in a randomised fashion and completed 12 months follow up. At the last study visit they signed a consent form to confirm that they have agreed to keep implanted loop recorder for the duration of its battery life time (approximately 3 years). They have also continued to regularly transfer data from their implanted loop recorder to the secure server where it is regularly reviewed. This group of patients is now a unique cohort whose follow up data is invaluable for additional research. For this study we will ask for their written consent and apart from analysing their heart rhythm data we will arrange two hospital visits with some additional tests and completion of questionnaires.
The principal objective of the study is to compare the long-term effectiveness of thoracoscopic surgical ablation and percutaneous catheter ablation, the two procedures available for treatment of atrial fibrillation in patients with longstanding persistent AF (LSPAF). There is some evidence that thoracoscopic surgical ablation may be better than catheter ablation in keeping the patients in regular heart rhythm after a single procedure without use of antiarrhythmic drugs in short term. In this study we plan to monitor patients who have undergone these procedures for 3 years.
Our secondary objectives are focussing on patients who had more than one procedure and/or may be using medications in order to maintain regular heart rhythm during 36 months follow up.
We will therefore look at:
- the effectiveness of a single procedure (catheter or surgical) in maintaining normal rhythm with use of antiarrhythmic drugs.
- the effectiveness of multiple ablative procedures in maintaining sinus rhythm with and without use of antiarrhythmic drugs.
- the proportion of patients who are still in AF but the time they spend in it is reduced by ≥75%. We will also want to examine:
- patient reported change in quality of life from baseline to 24 and 36 months after ablative treatment.
- changes in levels of serum biomarkers from baseline to 36 months and how they relate to the freedom of arrhythmia
- health and social care resource use and associated costs from baseline to 36 months
- the cost-effectiveness of thoracoscopic surgical ablation compared with catheter ablation and update the health economic model developed for the main study (CASA AF RCT).
Our sample size calculations show that with an expected rate of attrition of around 20% we need 94-100 study participants to show the difference in the effectiveness of the two procedure with power of 80%, p= 0.05.
Patients participating in this extended follow-up study will attend two hospital appointments to coincide with 24 and 36 months post-ablation (± 6 months). These two visits will consist of:
- clinical examination
- review of concurrent medications and comorbidities
- electrocardiogram (12 lead ECG )
- blood test for routine biochemistry and collection of a sample for biomarkers analyses
- completion of questionnaires to assess patients' quality of life: atrial fibrillation effect on quality of life (AFEQT), EuroQol (EQ5D5L) European Heart Rhythm Association score of atrial fibrillation (EHRA),
- Health economic questionnaire to capture repeat procedures (ablation, direct current cardioversion and AF-related emergency care)
For the duration of the extended follow-up, once a week patients will download data from their implantable loop recorders which have algorithms that are specific for atrial arrhythmias (atrial fibrillation, atrial tachycardia, atrial flutter). Patients remotely download their data to the Medtronic (MyCarelinkTM) secure server. These data will be reviewed centrally every month by a dedicated Research Fellow. Patients will be contacted monthly by telephone to ensure compliance and to discuss any rhythm abnormalities detected in these data that require review of treatment/ management. Patients will be able to contact the research team if they experience symptoms of atrial arrhythmias. The implanted loop recorder data can be interrogated remotely, and appropriate advice regarding treatment given based on data review.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic surgical ablation | – | –Participants in CASA AF Trial who underwent thoracoscopic surgical ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use. |
| Cather ablation | – | –Participants in CASA AF Trial who underwent conventional catheter ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with long standing persistent atrial fibrillation who took part in the CASA AF clinical trial and underwent one of the intervetions: catheter ablation or surgical thoracoscopic ablation. These patients have agreed to keep their implanted loop recorders and continued to dowload their data.
Key inclusion criteria (1 listed)
- CASA-AF RCT participants who have undergone ablative procedure to treat their LSPAF, completed 12 months follow up and consented to keep their implanted loop recorders in situ with weekly data downloads.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of a single ablative procedure
Time frame: over the duration of the followup period (24 months)
Freedom from continuous atrial arrhythmia (≥120 seconds in duration) recorded by implantable loop recorder or other clinically indicated rhythm recording device and absence of anti-arrhythmic drugs on concurrent medications form.
4 secondary outcomes
Reduction of burden of atrial fibrillation
Time frame: over the duration of the followup period (24 months)
AF related quality of life
Time frame: at 24 and 36 months from the ablative treatment
Quality of life assessment
Time frame: at 24 and 36 months from the ablative treatment
Changes in concentration of serum biomarkers (pg/ml)
Time frame: from baseline to 36 months after the ablative procedure
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 2 May 2022.
- 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. This study is not recruiting at the moment.
Tom Wong principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Standing Persistent Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation 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 1 inclusion and 1 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 2 May 2022. 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?
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?
Effectiveness of a single ablative procedure (time frame: over the duration of the followup period (24 months)). 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 2 May 2022.