Assessment of Left Atrial Mechanical Function With a True 3D Ultrasouns Arry and Comparison With the Transthoracic and Transesophageal Echocardiography

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.

Study Overview

• Status: Unknown
• Conditions: Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography
• Intervention / Treatment: Device: transesophageal investigation

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:

1. Fixed heart rate by atrial pacing
2. Apnea initiated at the end of expiration (apnea endexp)
3. 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8027
    • Recruiting
    • Klinik im Park
    • Contact: Werner Baulig, MD; Phone Number: +41 44 209 28 75; Email: werner.baulig@hirslanden.ch
    • Contact: Christoph Scharf, MD; Phone Number: +41 44 209 29 00; Email: christoph.scharf@hirslanden.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing electrophysiological study with the AcQmap System
• Age ≥18 years and signed informed consent
• German speaking

Exclusion Criteria:

• Mechanical mitral valve
• Contraindication for left atrial ablation procedure such as: Intra-cardiac clot,
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: transesophageal echocardiography; Comparison of 3D Ultrasound with transesophageal echokardiography	Device: transesophageal investigation; Comparison of 3D ultrasound with transesophageal echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in Mitral flow velocity	1 hour
changes in pulmonary vein flow	1 hour
changes in left atrial appendage flow	1 hour

Collaborators and Investigators

• Sponsor: Klinik Hirslanden, Zurich
• Investigators: Principal Investigator: Werner Baulig, MD, Klinik Im Park, Hirslanden, Zürich, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: 3 D Ultrasound, left atrium, Mitral inflow velocity, systolic and diastolic ventricular function
• Other Study ID Numbers: KlinikHirslanden

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
• product manufactured in and exported from the U.S.: No