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

NCT03331029 | Unknown

• 1 other identifier: KlinikHirslanden
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Comparison of 3D Monitored Changes of Left Atrial Volume Before and After Ablation With Conventional Transesophageal Echocardiography

Keywords

3 D Ultrasound, left atrium, Mitral inflow velocity, systolic and diastolic ventricular function

Outcome Measures

Primary Outcomes (3)

• Changes in Mitral flow velocity

  1 hour

• changes in pulmonary vein flow

  1 hour

• changes in left atrial appendage flow

  1 hour

Study Arms (1)

transesophageal echocardiography

OTHER

Comparison of 3D Ultrasound with transesophageal echokardiography

Device: transesophageal investigation

Interventions

transesophageal investigation DEVICE

Comparison of 3D ultrasound with transesophageal echocardiography

transesophageal echocardiography

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Klinik Hirslanden, Zurich: lead

Study Sites (1)

Klinik Im Park

Zurich, 8027, Switzerland

RECRUITING

MeSH Terms

Conditions

Systolic Murmurs

Condition Hierarchy (Ancestors)

Heart Murmurs; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Werner Baulig, MD

  Klinik Im Park, Hirslanden, Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Werner Baulig, MD

CONTACT

+41 44 209 28 75; werner.baulig@hirslanden.ch

Christoph Scharf, MD

CONTACT

+41 44 209 29 00; christoph.scharf@hirslanden.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Werner Baulig, Senior consultant

Model Details: Single Center interventional study

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)