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P-wave Analysis for Risk Evaluation of Ischemic Cerebral Embolism in Patients with Left Atrial Fibrosis- A Prospective Observational

P-wave Analysis for Risk Evaluation of Ischemic Cerebral Embolism in Patients with Left Atrial Fibrosis- A Prospective Observational - PARIS-AF Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030397
Enrollment
400
Registered
2022-10-10
Start date
2021-10-14
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

I48 I63

Interventions

Group 1: Duration of the amplified p-wave >137 ms or presence of advanced interatrial block (pos-neg P in two of the three inferior ECG leads) Group 2: Duration of the amplified p-wave < 137 ms withou

Sponsors

Universitätsklinikum FreiburgCampus Bad Krozingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: - Male and female patients aged =50 years and <85 years - Digital amplified 12-Lead-ECG available in normal sinus rhythm - 12-leads ECG recorded as part of the admission examination in all patients admitted to our center will be scrutinized regarding p-wave duration - Written informed consent for study participation prior to enrollment

Exclusion criteria

Exclusion criteria: - Prior cardiac surgery - Known atrial fibrillation, atrial flutter or atrial tachycardia - Current clinical indication for oral anticoagulant therapy - Prior catheter ablation for atrial fibrillation, atrial flutter or atrial tachycardia within the right and/or left atrium - Patients with implanted cardiac devices / pacemaker / ICD - Contra-indications for cerebral MRI like e.g. claustrophobia, carriage of metal implants - Short life expectancy due to comorbid conditions - Heart failure, NYHA 4 - Severe valvular heart disease (Mitral or aortic valvulopathy >Grade 2/3) - Other major disabling disease - Acute inflammatory or infectious disease - Body mass index (BMI): =18.0 and = 36.0 kg/m² - Female patients of child-bearing potential

Design outcomes

Secondary

MeasureTime frame
•Evaluation of the rate of clinically overt ischemic stroke/transient ischemic attack or new cerebral infarcts by MRI during the 18- and/or 36-months follow-up period in patients with vs without FAM (based on APWA) - Evaluation of Incidence of new-onset atrial fibrillation or flutter.

Primary

MeasureTime frame
The primary objective of the current pilot study is to assess the prevalence and incidence of stroke and silent cerebral infarcts by MRI at study inclusion and at 18 and 36 months FU in patients without and with electrocardiographic evidence of FAM (fibrotic atrial cardio-myopathy).

Countries

Germany

Contacts

Public ContactKilian Franke

Universitätsklinikum FreiburgCampus Bad Krozingen

kilian.franke@uniklinik-freiburg.de07633 402 4284

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026