Cerebral Embolization During Pulmonary Vein Isolation (TCD-CA)

Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Atrial Fibrillation; Cerebral Microembolism
• Intervention / Treatment: Procedure: QMODE intervention; Procedure: QMODE+ intervention

Detailed Description

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 +)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Tim B Brämswig, MD; Phone Number: +4930450560624; Email: tim-bastian.braemswig@charite.de
• Study Contact Backup: Name: Regina von Rennenberg, MD; Phone Number: +493084454285; Email: regina-irene.freiin-von-rennenberg@charite.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité-University Medicine Berlin, Campus Benjamin Franklin
    • Contact: Tim B Brämswig, MD
    • Contact: Regina von Rennenberg, MD
    • Principal Investigator: Christian H Nolte, MD
    • Sub-Investigator: Martin Huemer, MD
    • Sub-Investigator: Philipp Attanasio, MD
    • Sub-Investigator: Verena Tscholl, MD
    • Sub-Investigator: Tobias Schreiber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
QMODE intervention; catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and	Procedure: QMODE intervention; 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; catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +)	Procedure: QMODE+ intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microembolic Signals (MES)	number of MES detected by transcranial doppler ultrasound	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurological outcome	neurological outcome will be evaluated using the National Institute of Health Stroke Scale	at baseline, 0-5 days after pulmonary vein isolation
cognitive outcome	cognitive outcome will be evaluated using the Montreal Cognitive Assessment	at baseline, 0-5 days after pulmonary vein isolation
cerebral infarctions	number of new cerebral infarctions on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation
cerebral microbleeds	number of new cerebral microbleeds on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation
cerebral macrobleeds	number of new cerebral macrobleeds on magnetic resonance imaging	at baseline, 0-5 days after pulmonary vein isolation

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Christian H Nolte, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: EA1/215/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No