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NCT Number: NCT02814851

Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion

The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed during the third week of gestation. LAA is believed to function as a decompression chamber during left ventricular systole and other periods when left atrial pressure is elevated. The LAA is also a major endocrine organ and is the main producer of ANP (atrial natriuretic peptide) in the human heart. The ANP concentration is 40 times higher in the LAA walls than in the rest of the atrial wall. A study of patients having undergone the maze procedure and associated LAA removal found a significantly lower ANP secretion and an increase in salt and water retention. Whether this could eventually lead to hypertension or heart failure symptoms is not known.

Removal of the LAA is routinely performed during antiarrhythmic surgical techniques ("MAZE surgery") to reduce the risk of subsequent LAA thrombus. Furthermore, new percutaneous ablation techniques target LAA to reduce further risks of atrial fibrilation recurrences. However, in addition to effects on diastolic atrial function and atrial natriuretic peptide (ANP) secretion, this could potentially reduce stroke volume and cardiac output and may thus promote heart failure. Its removal could be particularly detrimental in patients with existing heart failure and high intraatrial pressure, as it would further promote pulmonary congestion and also reduce their cardiac output.

The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be prospectively included during the first 6 months following the onset of the protocol. Echocardiographic and invasive data will be collected simultaneously.

The goals of the study are:

* To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion will be measured using transesophageal echocardiography and hemodynamic measurement of the cardiac output. * To correlate echocardiographic parameters with in situ hemodynamic data.

A significant role of the LAA in the cardiac hemodynamic including the left ventricle outflow might have different clinical implications and will raise questions about:

* Appropriateness of LAA resection in antiarrhythmic surgery * Importance of restoring sinus rhythm in atrial fibrilation patients * Importance to spare LAA from ablation during atrial fibrilation ablation to avoid significant consequences on cardiac function. * Appropriateness of the LAA occluding device in atrial fibrillation patients.

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Key information

Conditions

Cardiac Surgery Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic valve stenosis suitable to surgery
  • Left Atrium<50 mm in the parasternal long axis view
  • Sinus rhythm at the time of patient's inclusion and during the procedure

Exclusion criteria

  • Hypertrophic cardiomyopathy (diastolic septal thickness > 15mm).
  • Heart failure with Left Ventricule Ejection Fraction < 45%.
  • Significant mitral regurgitation/stenosis
  • Significant aortic regurgitation
  • History of atrial fibrillation
  • Presence of prosthetic valves
  • Complex congenital heart disease

Treatment and study plan

Transesophageal echocardiogram

Device

All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann. A transesophageal echocardiogram (TEE) will be performed and the TEE probe will stay continuously during the entire procedure, to allow all necessary measurements.

Thermistor-tipped catheter

Device

All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a thermistor-tipped catheter (model 93A-131-7F, Edwards, Santa Ana, CA) will be inserted into the pulmonary artery to measure right atrial pressure (Pra), pulmonary arterial pressure (Ppa), Ppao and thermodilution cardiac output. Ringer's lactate will be infused to maintain an occluded pulmonary arterial pressure (Ppao) of 8-10 mmHg.

Pressure/volume catheter

Device

All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a pressure/volume catheter (CD Leicom, Zoetermeer, Netherland) will be placed in the left ventricle through a left superior pulmonary vein purse string, in order to measure alternatively LV pressure/volume loops and LA pressure.

Transthoracic echocardiography

Device

A complete transthoracic echocardiography will be performed the day before the surgical procedure. It will establish the presence of the inclusion and exclusion criteria, as stipulated above. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).

During the surgical procedure, a transesophageal echocardiogram will be performed, using an Acuson Sequoia system (Siemens AG, Germany).

Primary outcomes

  1. Left atrium (LA) dP/dt max

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  2. Left atrium dP/dt max

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  3. Left atrium output

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).

  4. Left atrium output

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).

  5. Left atrium contractility index (dP/dt max)/P

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  6. Left atrium contractility index (dP/dt max)/P

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  7. Left ventricle (LV) dP/dt max

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  8. Left ventricle dP/dt max

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  9. Left ventricle output

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).

  10. Left ventricle output

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).

  11. LV contractility index (dP/dt max)/P

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.

  12. LV contractility index (dP/dt max)/P

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.

  13. Occluded pulmonary arterial pressure (Ppao)

    Time frame: Baseline (before LAA clamping)

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

  14. Occluded pulmonary arterial pressure (Ppao)

    Time frame: 5 minutes after LAA clamping

    Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

Secondary outcomes

  1. Area fractional shortening (AFS) of the left atrium appendage (LAA)

    Time frame: Baseline (before LAA clamping)

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: AFS 2CME90°= (Amax-Amin)/Amax.

  2. Area fractional shortening (AFS) of the left atrium appendage (LAA)

    Time frame: 5 minutes after LAA clamping

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: AFS 2CME90°= (Amax-Amin)/Amax.

  3. Ejection volume of the LAA (left atrium appendage)

    Time frame: Baseline (before LAA clamping)

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: LAA ejection volume= 3,14*D1*D2*TVI PW LAA/4, where D1 and D2 are the diameters of the opening of the LAA at 0° and 90°

  4. Ejection volume of the LAA (left atrium appendage)

    Time frame: 5 minutes after LAA clamping

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: LAA ejection volume= 3,14*D1*D2*TVI PW LAA/4, where D1 and D2 are the diameters of the opening of the LAA at 0° and 90°

  5. Stroke volume

    Time frame: Baseline (before LAA clamping)

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: Stroke volume= 3,14D²*Aortic PW TVI /4, where D is the LVOT (left ventricular outflow tract)diameter in A3C.

  6. Stroke volume

    Time frame: 5 minutes after LAA clamping

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: Stroke volume= 3,14D²*Aortic PW TVI /4, where D is the LVOT (left ventricular outflow tract) diameter in A3C.

  7. Amplitude of the emptying pulse wave of the LAA (left atrium appendage)

    Time frame: Baseline (before LAA clamping)

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). 2C ME 90° measure

  8. Amplitude of the emptying pulse wave of the LAA (left atrium appendage)

    Time frame: 5 minutes after LAA clamping

    Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). 2C ME 90° measure

  9. TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)

    Time frame: Baseline (before LAA clamping)

    Transgastric or deep transgastric aortic Pulse Wave Doppler. 2C ME 90° measure

  10. TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)

    Time frame: 5 minutes after LAA clamping

    Transgastric or deep transgastric aortic Pulse Wave Doppler. 2C ME 90° measure

  11. Amplitude of the mitral A wave

    Time frame: Baseline (before LAA clamping)

    Amplitude A wave: measured with DTI (Tissue Doppler ) 4C ME 0° lateral ring

  12. Amplitude of the mitral A wave

    Time frame: 5 minutes after LAA clamping

    Amplitude A wave: measured with DTI (Tissue Doppler ) 4C ME 0° lateral ring

  13. TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)

    Time frame: Baseline (before LAA clamping)

    Measured by aortic Pulse Wave (PW) Doppler flow

  14. TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)

    Time frame: 5 minutes after LAA clamping

    Measured by aortic Pulse Wave (PW) Doppler flow

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2016
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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