Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04280042 |
Other study ID # |
271930 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2020 |
Est. completion date |
February 1, 2022 |
Study information
Verified date |
April 2022 |
Source |
Royal Brompton & Harefield NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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. 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.
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:
1. the effectiveness of a single procedure (catheter or surgical) in maintaining normal
rhythm with use of antiarrhythmic drugs.
2. the effectiveness of multiple ablative procedures in maintaining sinus rhythm with and
without use of antiarrhythmic drugs.
3. 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:
4. patient reported change in quality of life from baseline to 24 and 36 months after
ablative treatment.
5. changes in levels of serum biomarkers from baseline to 36 months and how they relate to
the freedom of arrhythmia
6. health and social care resource use and associated costs from baseline to 36 months
7. 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:
1. clinical examination
2. review of concurrent medications and comorbidities
3. electrocardiogram (12 lead ECG )
4. blood test for routine biochemistry and collection of a sample for biomarkers analyses
5. 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),
6. 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.