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Cerebral Embolization During Pulmonary Vein Isolation

Study acronym: TCD-CA
StatusUnknown
PhaseNot specified
Started2021-12-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-08-19
Study Status v2
Trial statusRecruiting→Unknown
Primary completion date2024-06→2025-06
Completion date2024-12→2025-12
2023-09-06
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-09→2024-06
Completion date2022-09→2024-12
Start dateestimated 2021-09→confirmed 2021-12-01
InterventionsPulmonary Vein Isolation (Procedure)→QMODE intervention (Procedure), QMODE+ intervention (Procedure)
Eligibility criteria-104 characters
Inclusion Criteria: patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin [...] pregnancy patient unable to provide written informed consent contraindications to cerebral MRI (e.g. pacemaker, mechanic valve implant, cochlea implant, severe claustrophobia)
Study description+17 characters
[...] microemboli in different pulmonary vein isolation techniques, thatnamely arehigh-power appliedwith ina clinicalmaximum routineof asup wellto as50 differentW periprocedural(QMODE) anticoagulationand regimes.very high power with a maximum of up tp 90 W (QMODE +)
Study sitesdetails revised at 1 of 1 site
2021-09-16
Original filing
The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.
Trial Details
NCT Number NCT05048004
Lead Sponsor Charite University, Berlin, Germany
Conditions Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism
Enrollment 20 participants
Start Date 2021-12-01
Primary Completion 2025-06 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-20