Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02814851
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion
Sponsor:
Brugmann University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: