Evaluation of cerebral microembolism related to left atrial ablation of paroxysmal atrial fibrillation

Evaluation of cerebral microembolism related to left atrial ablation of paroxysmal atrial fibrillation - SCM-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003465

Enrollment

150

Registered

2012-01-05

Start date

2011-08-01

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

I48.10 I63.4

Interventions

Group 1: Evaluation of cerebral microembolism during ablation of atrial fibrillation using the PVAC (catheter for mapping and ablation) Group 2: Evaluation of cerebral microembolism during ablation of

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with paroxysmal atrial fibrillation scheduled for pulmonary vein isolation (PVI alone, no additional ablation) 2. Provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Age 80 years 2. Prior Stroke 3. Dementia 4. Prior pulmonary vein isolation 5. Severe claustrophobia 6. Implanted pacemaker/ICD (no MRI possible) 7. Persistent atrial fibrillation

Design outcomes

Primary

Measure	Time frame
Composite endpoint of cerebral microembolisms demonstrated by cerebral magnetic resonance imaging (the day before and two days and one month after the procedure), microembolisms recorded by transcranial doppler (during the procedure) and neuropsychological events measured by trail making test A, trail making test B, controlled oral word association test, block tapping test und Ruff 2&7 test (the day before and two days and one month after the procedure).	—

Measure

Time frame

Composite endpoint of cerebral microembolisms demonstrated by cerebral magnetic resonance imaging (the day before and two days and one month after the procedure), microembolisms recorded by transcranial doppler (during the procedure) and neuropsychological events measured by trail making test A, trail making test B, controlled oral word association test, block tapping test und Ruff 2&7 test (the day before and two days and one month after the procedure).

—

Secondary

Measure	Time frame
Influence of periprocedural management and technical settings on the occurence of cerebral microembolisms	—

Countries

Germany

Contacts

Public ContactChristian von Bary

Klinik und Poliklinik für Innere Medizin II Universitätsklinikum Regensburg

christian.von-bary@ukr.de+49-2159-81490

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 27, 2026