Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04300270 |
| Other study ID # |
SmartBeats |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 27, 2018 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Karolinska Institutet |
| Contact |
Johan Engdahl |
| Phone |
+46812358242 |
| Email |
johan.engdahl[@]ki.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Atrial fibrillation is a heart rhythm disorder with increased risk of stroke, heart failure,
dementia and death. The severity of symptoms in atrial fibrillation varies markedly, ranging
from no symptoms to those with disabling symptoms. An ECG recording is currently mandatory
for diagnosing atrial fibrillation. A portable method for heart rhythm diagnostics that is
readily available is currently missing in clinical practice. If a standard smartphone could
be used for heart rhythm diagnostics, the availability could improve greatly.
Treatment with direct current cardioversion is a procedure in which the heart rhythm is
normalized by an electrical shock through the chest. Patients with atrial fibrillation are in
some cases recommended treatment with direct current cardioversion but the procedure is
costly, has a high recurrence rate and includes an increased risk for stroke. In this study
we will validate the use of a novel smartphone-based method for heart rhythm diagnostics when
used by patients in their home environment. The novel method is using the smartphone camera
as a sensor. Patients will be doing heart rhythm measurements with the novel smartphone-based
method in their home environment for 30 days after successfully receiving treatment of atrial
fibrillation with direct current cardioversion. The novel smartphone-based method will be
validated against simultaneous recordings with mobile ECG.
We will also study the feasibility in using smartphone recordings and mobile ECG in the home
environment the weeks before receiving treatment with direct current cardioversion, to study
the possible benefit of detecting spontaneous conversions to normal heart rhythm and missed
doses of treatment with blood thinning medication, both of which will lead to cancellation or
detention of the cardioversion procedure.
Description:
Atrial fibrillation is a heart rhythm disorder with increased risk of stroke, heart failure,
dementia and death. The severity of symptoms in atrial fibrillation varies markedly, ranging
from no symptoms to those with disabling symptoms. An ECG recording is currently mandatory
for diagnosing atrial fibrillation.
The availability of long-term ECG and portable ECG registration for heart rhythm diagnostics
within the healthcare sector is severely limited by waiting time both for ECG recording and
for analysis and reporting. A method for heart rhythm diagnostics that is readily available
is currently lacking in clinical practice, except for hospitalization, which is very costly
and has low availability.
The lack of a method for diagnosis of heart rhythm disorders and atrial fibrillation that is
readily available, cost-effective and simple to use is a problem for both the patients and
for the healthcare system as a whole. The limited availability of patient-related diagnostics
thus means that many patients, even those with symptoms, remain undiagnosed and thus
untreated, which in turn means that the missing diagnosis gives an increased risk of stroke.
If a standard smartphone could be used for reliable heart rhythm diagnostics, the
availability could improve greatly.
Treatment with direct current cardioversion is a procedure in which the heart rhythm is
normalized by an electrical shock through the chest. Patients with atrial fibrillation could
in some cases be treated with cardioversion but the procedure is costly, has a high
recurrence rate and includes an increased risk for thromboembolism and stroke. The benefit of
the treatment is mainly symptomatic, with no proven long-term effects of mortality or
morbidity.
In this study we will validate the use of a novel smartphone-based method for heart rhythm
diagnostics when used by patients in their home environment after receiving treatment with
direct current cardioversion. The novel method is using the smartphone camera as a sensor and
records photoplethysmographic (PPG) measurements. We will also study the feasibility in using
smartphone and mobile ECG recordings peri-cardioversion, to study the possible benefit of
detecting pre-cardioversion spontaneous conversions to sinus rhythm and non-adherence to
treatment with oral anticoagulants, both of which will lead to cancellation or detention of
the cardioversion procedure. We will also detect the timing of post-cardioversion early
recurrences into atrial fibrillation, as well as the heart rate and symptoms associated to
recurrence, if any.
The objective of this study is to:
1. Validate heart rhythm measurements registered with a novel smartphone-based method using
PPG-measurement technology compared to mobile ECG technology in patients with atrial
fibrillation. The validation involves evaluating whether PPG-measurement technology
using a novel smartphone-based method provides sufficient diagnostic performance in the
home environment / outpatient environment compared to outpatient mobile ECG
measurements.
2. Study if pre-cardioversion heart rhythm recordings will reduce the number of same day
cancellations of treatment of atrial fibrillation with planned direct current
cardioversion.
For the validation part, patients who visit the cardiac day care department at the department
of Cardiology, Danderyd University Hospital, for treatment with outpatient direct current
cardioversion of atrial fibrillation or atrial flutter are asked about participating by
physicians or research nurses. Each patient will prior to inclusion in the study be given
full and adequate verbal and written information regarding the objective and procedures of
the study and possible risks involved. Written consent is obtained from the physician or
research nurse.
A 60-second heart rhythm measurement using a smartphone is recorded before the patient
receives treatment with direct current cardioversion. The smartphone used is the same device
that the patient will be using in their home for 30 days after the treatment. The measurement
includes PPG-measurement from the camera of the smartphone as well as a simultaneous one lead
ECG-registration done with a small ECG-device attached to the back of the smartphone.
The patient is interviewed about their medical history and their current symptoms. If the
treatment is successful and the patient's heart rhythm is converted back to normal sinus
rhythm, the patient is included in the study. The patient's heart rhythm is verified with an
ECG measurement recorded approximately one hour after the cardioversion treatment.
When the patients are discharged from the hospital they are given a smartphone that they will
be recording simultaneous PPG- and ECG-recordings with, at least twice daily for a period of
30 days post-cardioversion in their home.
For the clinical implementation part, patients scheduled for direct current cardioversion at
Danderyd University Hospital will be included at least 2 weeks prior to the scheduled
treatment. Information regarding co-morbidities, echocardiographic parameters and current
medication will be collected from interviews and medical records.
All individuals scheduled for direct current cardioversion will be invited to a screening
visit and asked to sign a written consent form. After consent, their heart rhythm will be
recorded and those with sinus rhythm will be excluded. Participants with atrial fibrillation
or atrial flutter will be randomized 1:1 to pre-cardioversion heart rhythm monitoring, or no
monitoring pre-cardioversion.
Participants randomized to active pre-cardioversion rhythm monitoring (intervention group)
will be instructed in the use of smartphone rhythm recordings (using simultaneous PPG and
mobile ECG). They will be recording both their heart rhythm and oral anticoagulant treatment
adherence with the same smartphone application. This information will give the investigators
the possibility to cancel or postpone the scheduled cardioversion visit in advance for those
with spontaneous rhythm conversion to sinus rhythm and for those with non-adherence to oral
anticoagulant treatment.
Participants randomized to passive pre-cardioversion rhythm monitoring (control group) will
be instructed in the use of smartphone rhythm recordings (using simultaneous PPG and mobile
ECG). The control group will be recording only heart rhythm and not treatment adherence. The
heart rhythm recordings made in the control group will be reviewed after the participants
treatment with direct current cardioversion.
After the treatment with direct current cardioversion, all participants are followed up in
one common cohort.
