Atrial FibrillationTCD-CANCT05048004
Cerebral Embolization During Pulmonary Vein Isolation
An observational study of Atrial Fibrillation and Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism
- What is being tested?
- QMODE intervention and QMODE+ intervention
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin
- age 18 years or older
Who cannot join
- pregnancy
- patient unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité-University Medicine Berlin, Campus Benjamin Franklin
Berlin, 12203
Tim B Brämswig, MD
Regina von Rennenberg, MD
About this study
Official title: 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.
Read the 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 +)
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism
- Being tested
- QMODE intervention, QMODE+ intervention
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMODE interventionProcedure or surgery
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+ interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| QMODE intervention | catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and Receives: Procedure: QMODE intervention | |
| QMODE+ intervention | catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) Receives: Procedure: QMODE+ intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microembolic Signals (MES)
number of MES detected by transcranial doppler ultrasound
Measured: during the procedure
Secondary outcomes (5)
neurological outcome
neurological outcome will be evaluated using the National Institute of Health Stroke Scale
Measured: at baseline, 0-5 days after pulmonary vein isolation
cognitive outcome
cognitive outcome will be evaluated using the Montreal Cognitive Assessment
Measured: at baseline, 0-5 days after pulmonary vein isolation
cerebral infarctions
number of new cerebral infarctions on magnetic resonance imaging
Measured: at baseline, 0-5 days after pulmonary vein isolation
cerebral microbleeds
number of new cerebral microbleeds on magnetic resonance imaging
Measured: at baseline, 0-5 days after pulmonary vein isolation
cerebral macrobleeds
number of new cerebral macrobleeds on magnetic resonance imaging
Measured: at baseline, 0-5 days after pulmonary vein isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Dec 2021
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nolte, Charite University, Berlin, Germany
- Investigators
- Christian H Nolte, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048004
- Sponsor's protocol ID
- EA1/215/20
- Acronym
- TCD-CA
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study
- ClinicalTrials.gov ID
- NCT05048004
- Acronym / sponsor ID
- TCD-CA / EA1/215/20
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Cerebral Microembolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QMODE intervention | – | Procedure: QMODE interventioncatheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and |
| QMODE+ intervention | – | Procedure: QMODE+ interventioncatheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin
- age 18 years or older
Key exclusion criteria (2 listed)
- pregnancy
- patient unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMODE interventionPatients 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). | Procedure or surgery | QMODE intervention |
| QMODE+ interventionPatients 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. | Procedure or surgery | QMODE+ intervention |
Primary outcome
Microembolic Signals (MES)
Time frame: during the procedure
number of MES detected by transcranial doppler ultrasound
5 secondary outcomes
neurological outcome
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cognitive outcome
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral infarctions
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral microbleeds
Time frame: at baseline, 0-5 days after pulmonary vein isolation
cerebral macrobleeds
Time frame: at baseline, 0-5 days after pulmonary vein isolation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian H Nolte, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tim B Brämswig, MD (+4930450560624, tim-bastian.braemswig@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microembolic Signals (MES) (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.