Cerebral Embolization During Pulmonary Vein Isolation

NCT05048004 | Recruiting

• 1 other identifier: EA1/215/20
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Ischemic Stroke; Cerebral Microembolism

Outcome Measures

Primary Outcomes (1)

• Microembolic Signals (MES)

  number of MES detected by transcranial doppler ultrasound

  during the procedure

Secondary Outcomes (5)

• neurological outcome

  at baseline, 0-5 days after pulmonary vein isolation

• cognitive outcome

  at baseline, 0-5 days after pulmonary vein isolation

• cerebral infarctions

  at baseline, 0-5 days after pulmonary vein isolation

• cerebral microbleeds

  at baseline, 0-5 days after pulmonary vein isolation

• cerebral macrobleeds

  at baseline, 0-5 days after pulmonary vein isolation

Study Arms (2)

QMODE intervention

catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and

Procedure: QMODE intervention

QMODE+ intervention

catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +)

Procedure: QMODE+ intervention

Interventions

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.

QMODE+ intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients who undergo pulmonary vein isolation as part of their treatment for atrial fibrillation at Charité-Campus Benjamin Franklin are eligible for study participation. Clinical indication for the procedure will be established by the treating physician prior to and irrespective of study participation. Patients who are unable to provide written informed consent will not be included in this study.

You may qualify if:

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

You may not qualify if:

• pregnancy
• patient unable to provide written informed consent

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité-University Medicine Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Ischemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Christian H Nolte, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim B Brämswig, MD

CONTACT

+4930450560624; tim-bastian.braemswig@charite.de

Regina von Rennenberg, MD

CONTACT

+493084454285; regina-irene.freiin-von-rennenberg@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 17, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)