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The nECG system: Identification and quantification of atrial fibrillation and the patient burden in patients with paroxysmal atrial fibrillation undergoing catheter ablation

The nECG system: Identification and quantification of atrial fibrillation and the patient burden in patients with paroxysmal atrial fibrillation undergoing catheter ablation - Identification and quantification of paroxysmal AF after catheter ablation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40289
Enrollment
15
Registered
2014-01-30
Start date
2014-03-20
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrium fibrillation heart rhythm disturbance

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)