Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal EchocardiographyNCT03331029
Assessment of Left Atrial Mechanical Function With a True 3D Ultrasouns Arry and Comparison With the Transthoracic and Transesophageal Echocardiography
A study testing transesophageal investigation in people with Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography, run by Klinik Hirslanden, Zurich at 1 site in Switzerland.
Trial summary
Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency ablation besides pulmonary vein isolation. Atrial contractility in these patients is often impaired. Until now mapping catheters were used on virtual geometry maps of left atrium. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography
- What is being tested?
- transesophageal investigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing electrophysiological study with the AcQmap System
- Age ≥18 years and signed informed consent
- German speaking
Who cannot join
- Mechanical mitral valve
- Contraindication for left atrial ablation procedure such as: Intra-cardiac clot,
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Klinik Im Park
Zurich, 8027
Werner Baulig, MD, +41 44 209 28 75, werner.baulig@hirslanden.ch
Christoph Scharf, MD, +41 44 209 29 00, christoph.scharf@hirslanden.ch
About this study
Official title: Assessment of Left Atrial Mechanical Function With a True 3D Ultrasound Array and Comparison With the Transthoracic and Transesophageal Echocardiography: A Single Center Interventional Study in Patients Scheduled for Ablation Procedure
Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency ablation besides pulmonary vein isolation. Atrial contractility in these patients is often impaired. Until now mapping catheters were used on virtual geometry maps of left atrium. However, changes in atrial volume cannot be assessed with these systems Assessments of atrial volumes with echocardiography relies on 2D and 3D measurements and modeling. The AcQMapTM 3D High Resolution Imaging and Mapping System (AcQMap) has a unique 3D array of ultrasound crystals, which can measure true 3D dimensions of the heart chamber. For the first time, true atrial volumes can be measured. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography.
Read the detailed description
Comparison of true 3D atrial volume changes to TEE and TTE findings as well as atrial pressure curves during left heart catheterization. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography
Measurement of true left atrial ejection fraction and comparison to 2D echocardiographic parameters such as transesophageal measured flow velocity of the mitral inflow tract, pulmonary vein flow, the left atrial appendage flow
Inclusion:
Patients undergoing electrophysiological study with the AcQmap System Age ≥18 years and signed informed consent German speaking
Exclusion:
Mechanical mitral valve Contraindication for left atrial ablation procedure such as: Intra-cardiac clot, Pregnancy
Data collection of ultrasound dimensions of left atrium, left atrial pressure and TEE is performed simultaneously under the following conditions:
- Fixed heart rate by atrial pacing
- Apnea initiated at the end of expiration (apnea endexp)
- With and without complete atrioventricular bloc Under these conditions pressure volume loops are monitored. Simultaneously mitral annulus velocity (septal and lateral), pulmonary vein flow, left atrial appendage flow (max. A and V velocity) and LAA volume (average of 4 planes) are measured
The AcQMap Catheter consists of 6 splines with 48 electrodes and ultrasound crystals, which form a true 3D array of about 2 cm diameter. The catheter can be collapsed for introduction over a sheet into the right or left atrium and is used to record electrical bio potentials of the atrium. Besides each electrode is an ultrasound crystal, which measures the distance to the atrial wall at a sample rate 100000/min a ultrasound based anatomy of the atrium is constructed. The procedure of introduction the AcQMap catheter is in the right or left atrium is the same as it is performed with the standard devices for mapping and treating the atrial fibrillation in humans.
Analysis of changes in the collected data before and after ablation procedure is performed using unpaired t-test and non-parametric interrogation (Wilcoxon and Mann-Whithey U test) where otherwise appropriate (spss v 16, SPSS Chicago, IL, USA). Normal distributed date will be presented as mean ±SD and 95% confidence interval (CI95) and not normal distributed data will be presented as median and interquartile range (ICR). For repeated measures ANOVA will be used to estimate between-subject's variation and within-subject variation.
- Being tested
- transesophageal investigation
- Keywords
- 3 D Ultrasound, left atrium, Mitral inflow velocity, systolic and diastolic ventricular function
- Medical subject headings
- Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transesophageal investigationDevice
Comparison of 3D ultrasound with transesophageal echocardiography
| Study group | Role | What they receive |
|---|---|---|
| transesophageal echocardiography | Other | Comparison of 3D Ultrasound with transesophageal echokardiography Receives: Device: transesophageal investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mitral flow velocity
Measured: 1 hour
changes in pulmonary vein flow
Measured: 1 hour
changes in left atrial appendage flow
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal EchocardiographyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Center interventional study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Hirslanden, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Werner Baulig, Klinik Hirslanden, Zurich
- Investigators
- Werner Baulig, MD, Principal investigator, Klinik Im Park, Hirslanden, Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331029
- Sponsor's protocol ID
- KlinikHirslanden
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2017
- Last updated
- 8 Oct 2019
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Atrial Mechanical Function With a True 3D Ultrasound Array and Comparison With the Transthoracic and Transesophageal Echocardiography: A Single Center Interventional Study in Patients Scheduled for Ablation Procedure
- ClinicalTrials.gov ID
- NCT03331029
- Acronym / sponsor ID
- KlinikHirslanden
- Keywords
- 3 D Ultrasound, left atrium, Mitral inflow velocity, systolic and diastolic ventricular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klinik Hirslanden, ZurichUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Nov 2017 (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.
Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency ablation besides pulmonary vein isolation. Atrial contractility in these patients is often impaired. Until now mapping catheters were used on virtual geometry maps of left atrium. However, changes in atrial volume cannot be assessed with these systems Assessments of atrial volumes with echocardiography relies on 2D and 3D measurements and modeling. The AcQMapTM 3D High Resolution Imaging and Mapping System (AcQMap) has a unique 3D array of ultrasound crystals, which can measure true 3D dimensions of the heart chamber. For the first time, true atrial volumes can be measured. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography.
Detailed description
Comparison of true 3D atrial volume changes to TEE and TTE findings as well as atrial pressure curves during left heart catheterization. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography
Measurement of true left atrial ejection fraction and comparison to 2D echocardiographic parameters such as transesophageal measured flow velocity of the mitral inflow tract, pulmonary vein flow, the left atrial appendage flow
Inclusion:
Patients undergoing electrophysiological study with the AcQmap System Age ≥18 years and signed informed consent German speaking
Exclusion:
Mechanical mitral valve Contraindication for left atrial ablation procedure such as: Intra-cardiac clot, Pregnancy
Data collection of ultrasound dimensions of left atrium, left atrial pressure and TEE is performed simultaneously under the following conditions:
- Fixed heart rate by atrial pacing
- Apnea initiated at the end of expiration (apnea endexp)
- With and without complete atrioventricular bloc Under these conditions pressure volume loops are monitored. Simultaneously mitral annulus velocity (septal and lateral), pulmonary vein flow, left atrial appendage flow (max. A and V velocity) and LAA volume (average of 4 planes) are measured
The AcQMap Catheter consists of 6 splines with 48 electrodes and ultrasound crystals, which form a true 3D array of about 2 cm diameter. The catheter can be collapsed for introduction over a sheet into the right or left atrium and is used to record electrical bio potentials of the atrium. Besides each electrode is an ultrasound crystal, which measures the distance to the atrial wall at a sample rate 100000/min a ultrasound based anatomy of the atrium is constructed. The procedure of introduction the AcQMap catheter is in the right or left atrium is the same as it is performed with the standard devices for mapping and treating the atrial fibrillation in humans.
Analysis of changes in the collected data before and after ablation procedure is performed using unpaired t-test and non-parametric interrogation (Wilcoxon and Mann-Whithey U test) where otherwise appropriate (spss v 16, SPSS Chicago, IL, USA). Normal distributed date will be presented as mean ±SD and 95% confidence interval (CI95) and not normal distributed data will be presented as median and interquartile range (ICR). For repeated measures ANOVA will be used to estimate between-subject's variation and within-subject variation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Center interventional study
| Arm | Type | Receives |
|---|---|---|
| transesophageal echocardiography | Other | Device: transesophageal investigationComparison of 3D Ultrasound with transesophageal echokardiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing electrophysiological study with the AcQmap System
- Age ≥18 years and signed informed consent
- German speaking
Key exclusion criteria (3 listed)
- Mechanical mitral valve
- Contraindication for left atrial ablation procedure such as: Intra-cardiac clot,
- Pregnancy
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 |
|---|---|---|
| transesophageal investigationComparison of 3D ultrasound with transesophageal echocardiography | Device | transesophageal echocardiography |
Primary outcome
Changes in Mitral flow velocity
Time frame: 1 hour
changes in pulmonary vein flow
Time frame: 1 hour
changes in left atrial appendage flow
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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.
Werner Baulig, MD principal investigator
Klinik Im Park, Hirslanden, Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transesophageal investigation in people with Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography, run by Klinik Hirslanden, Zurich at 1 site in Switzerland.
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 3 inclusion and 3 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 8 Oct 2019. 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 Switzerland. 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 Werner Baulig, MD (+41 44 209 28 75, werner.baulig@hirslanden.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mitral flow velocity (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 8 Oct 2019.