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NCT Number: NCT05048004

Cerebral Embolization During Pulmonary Vein Isolation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Microembolism Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité-University Medicine Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location status: Recruiting

Location contact

Christian H Nolte, MD

PRINCIPAL_INVESTIGATOR

Martin Huemer, MD

SUB_INVESTIGATOR

Philipp Attanasio, MD

SUB_INVESTIGATOR

Regina von Rennenberg, MD

CONTACT

Tim B Brämswig, MD

CONTACT

Tobias Schreiber, MD

SUB_INVESTIGATOR

Verena Tscholl, MD

SUB_INVESTIGATOR

About this study

Pulmonary vein isolation (PVI) is a well-established interventional treatment of patients with atrial fibrillation. Previous studies have shown that catheter-based treatments such as PVI may lead to cerebral ischemia. Cerebral ischemia related to PVI may present with new neurological deficits but may also occur as "silent brain infarction". However, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. To date, it remains unclear which procedural steps of PVI are associated with an increased risk of cerebral ischemia.

Cerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (TCD). TCD has been used in clinical routine for many years and is known to be safe in stroke patients. By performing continuous TCD monitoring for microembolic signals during PVI, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. In addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 W (QMODE) and very high power with a maximum of up tp 90 W (QMODE +)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin
  • age 18 years or older

Exclusion criteria

  • pregnancy
  • patient unable to provide written informed consent

Treatment and study plan

QMODE intervention

Procedure

Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For standard ablation, a Thermocool Smarttouch SF (Biosense Webster) catheter will be used (50 W, target ablation index of 550).

QMODE+ intervention

Procedure

Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For comparison, catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) will be used.

Primary outcomes

  1. Microembolic Signals (MES)

    Time frame: during the procedure

    number of MES detected by transcranial doppler ultrasound

Secondary outcomes

  1. neurological outcome

    Time frame: at baseline, 0-5 days after pulmonary vein isolation

    neurological outcome will be evaluated using the National Institute of Health Stroke Scale

  2. cognitive outcome

    Time frame: at baseline, 0-5 days after pulmonary vein isolation

    cognitive outcome will be evaluated using the Montreal Cognitive Assessment

  3. cerebral infarctions

    Time frame: at baseline, 0-5 days after pulmonary vein isolation

    number of new cerebral infarctions on magnetic resonance imaging

  4. cerebral microbleeds

    Time frame: at baseline, 0-5 days after pulmonary vein isolation

    number of new cerebral microbleeds on magnetic resonance imaging

  5. cerebral macrobleeds

    Time frame: at baseline, 0-5 days after pulmonary vein isolation

    number of new cerebral macrobleeds on magnetic resonance imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Regina von Rennenberg, MD

CONTACT

[email protected]

+493084454285

Tim B Brämswig, MD

CONTACT

[email protected]

+4930450560624

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

Acronym: TCD-CA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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