1. Primary objectiveThe identification and discrimination of AF burden and the patient burden of the nECG system in patients with paroxysmal AF undergoing catheter ablation for AF.2. Secondary objectiveAssess the relation between the changes in…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AF burden and the possibility of arrhythmia identification (AF, atrial flutter,
atrial tachycardia) will be determined. Monitoring duration and patient
compliance will be documented from the duration of the recordings and patient
satisfaction will be measured using a questionnaire after the three week
monitoring period. Finally, the changes in biomarkers involved in the reverse
remodeling of the atrium in AF will be related to the burden of AF in the
preceding monitoring periods.
Secondary outcome
na
Background summary
Extending the duration of ambulatory electrocardiographic monitoring can
improve the detection of AF and may be useful in determining the burden of AF
in patients before and after treatment. The burden of AF might influence
underlying reverse remodelling processes involved in the pathophysiology of AF.
Biomarkers are a representation of these processes and insight in these
processes might guide clinical decision making. For monitoring an implantable
loop recorder can be implanted under the skin on the chest and monitor the
rhythm accurately for prolonged periods. However it is expensive and is a small
surgical procedure with the chance of small procedural risks. Non invasive
continuous monitoring (Holter) or longer term intermittent monitoring (event or
loop recorder) can be used as ambulatory monitoring devices. However, such
technologies have generally been limited by patient compliance, the analyzable
wear time and electrode skin irritation. Recently a novel wearable device for
extended ambulatory ECG monitoring (nECG) became available that might increase
patient compliance and accuracy of AF detection.
Study objective
1. Primary objective
The identification and discrimination of AF burden and the patient burden of
the nECG system in patients with paroxysmal AF undergoing catheter ablation for
AF.
2. Secondary objective
Assess the relation between the changes in biomarkers involved in the reverse
remodeling of the atrium in AF and the burden of AF in the preceding monitoring
period
Study design
This study is an observational two-center study.
Study burden and risks
The benefit of this study is that introduces a non-invasive comfortable
wearable monitoring device to ascertain the occurrence of AF. The nECG is more
comfortable and easier in use than a regular Holter. In addition it allows for
a longer monitoring duration, to increase the capture of AF occurrence. For
individual patients participating in the study, there is a higher chance of AF
documentation, due to the prolonged monitoring period, preventing a possible
repeat investigation to document AF. Therefore, the rhythm monitoring will
consist of three weeks instead of two days. Additionally, a total of 20ml of
extra blood will be sampled during routine blood tests investigation for
additional analysis of biomarkers. There is no risk to the patient when
participating in this study related to the nECG. There is a very limited chance
of allergic skin reactions (atopic eczema), due to the use of gel or the
detergent to wash the band. The monitoring device is safe and has received a CE
mark.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Any patient with an indication for catheter ablation treatment of symptomatic paroxysmal AF can enter the study.;The patients should conform to the following criteria:
• Age between 18 and 80 years
• Paroxysmal AF, as defined following the ESC 2010 Guidelines.
• At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
• Legally competent and willing to sing the informed consent.
• Willing and able to adhere to the follow up visit protocol.
Exclusion criteria
If any of the following criteria is present, patients cannot enter the study and will thus not be asked for written informed consent:
• Prior intervention (catheter ablation or minimally-invasive surgical ablation) for AF.
• AF secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
• Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5C)
• NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%. Cerebrovascular accident (defined as any sudden neurological deficit lasting longer than 24 hours, with or without pathological changes on the CT cerebrum) with the preceding 6 months
• Unable to undergo TEE
• Requirement of antiarrhythmic medication for ventricular arrhythmias
• Presence of intracardiac mass or thrombus (Discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the patient from the study)
• Circumstances that prevent follow up.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47181.018.13 |