Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01767220
Status:
UNKNOWN
Last Update Posted:
2014-01-30
First Post:
2013-01-07
Brief Title:
Endo- and Epicardial vs Endocardial Ablation of Ventricular Tachycardia in Patients With Cardiac Disease
Sponsor:
University of Rostock
Organization:
University of Rostock
Study Overview
Official Title:
Primary Endo- and Epicardial vs Endocardial Ablation of Sustained Ventricular Tachycardia in Patients With Underlying Cardiac Disease VTeee
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
RECRUITING
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:
VTeee
Brief Summary:
A significant portion of patients with cardiac diseases like coronary artery disease CAD dilated cardiomyopathy DCM and arrhythmogenic right ventricular cardiomyopathy ARVC develops ventricular tachycardia VT The standard ablation procedure is carried out from endocardial only In 30 of patients treated this way a successful ablation is not possible In these cases the scar areas are mostly located in the outer layer of the myocardium Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation
This prospective randomized trial compares the standard ablation procedure endocardial ablation only with a new strategy This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial The primary endpoint is recurrence of VT after endo- and epicardial vs endocardial ablation only
40 patients will be enrolled They will be randomized 11 in the study arms strategy 1 which is standard endocardial ablation and strategy 2 which is endo- and epicardial ablation
At least 12 months are planned for enrollment The study is closed if the patient last enrolled has completed the 12-months-follow up Follow up visits are scheduled 3 6 and 12 months after the ablation procedure Recurrence of VT is monitored by ICD implanted cardioverter defibrillator interrogation
Both ablation strategies are well established and conducted with standard equipment The methodology of this study does not contain any experimental approaches The standard insurance coverage of the hospital is guaranteed for all enrolled patients
This prospective randomized trial compares the standard ablation procedure endocardial ablation only with a new strategy This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial The primary endpoint is recurrence of VT after endo- and epicardial vs endocardial ablation only
40 patients will be enrolled They will be randomized 11 in the study arms strategy 1 which is standard endocardial ablation and strategy 2 which is endo- and epicardial ablation
At least 12 months are planned for enrollment The study is closed if the patient last enrolled has completed the 12-months-follow up Follow up visits are scheduled 3 6 and 12 months after the ablation procedure Recurrence of VT is monitored by ICD implanted cardioverter defibrillator interrogation
Both ablation strategies are well established and conducted with standard equipment The methodology of this study does not contain any experimental approaches The standard insurance coverage of the hospital is guaranteed for all enrolled patients
Detailed Description:
A significant portion of patients with cardiac diseases like coronary artery disease CAD dilated cardiomyopathy DCM and arrhythmogenic right ventricular cardiomyopathy ARVC develops ventricular tachycardia VT These arrhythmia often causes symptoms like dizziness shortness of breath angina or even cardiogenic shock Large trials showed that VTs are associated with a 34 to 5fold increase in mortality even if each episode was successfully terminated by an ICD Initially most patients are treated with antiarrhythmics If these drugs are ineffective or not tolerated because of side effects catheter ablation obliteration of cardiac tissue by radiofrequency is the only alternative therapy
The mechanism of most VTs are reentry circuits which are typically found in areas of scar in the left or right chamber These scar areas may be located in the inner layer of the myocardium endocardial in the outer layer epicardial or in all layers of the heart muscle transmural The standard ablation procedure is carried out from endocardial only This means catheters introduced through the femoral veins or arteries are placed in the right or left ventricle In 30 of patients treated this way a successful ablation is not possible In these cases the scar areas are mostly located in the outer layer of the myocardium Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation
This prospective randomized trial compares the standard ablation procedure endocardial ablation only with a new strategy This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial The primary endpoint is recurrence of VT after endo- and epicardial vs endocardial ablation only
Patients are eligible if they show documented VT on the basis of an underlying cardiac disease and a therapy with antiarrhythmics was ineffective or not tolerated In terms of this study cardiac disease means CAD DCM and ARVC All patients have to be treated with an ICD Patients are not eligible if VT is not documented if there is no structural heart disease if they have a mechanical aortic valve or a pacemakerICD with epicardial leads implanted or if a pericardial puncture must not be done
40 patients will be enrolled They will be randomized 11 in the study arms strategy 1 which is standard endocardial ablation and strategy 2 which is endo- and epicardial ablation
In case of strategy 1 ablation catheters are placed in the right left or both ventricles through the femoral veinsarteries VT is induced by programmed stimulation and then analysed By means of 3D-electroanatomical mapping the endocardial surface is reconstructed The scar areas are marked and in a second step obliterated
In case of strategy 2 in addition to the endocardial access via femoral veinsarteries a pericardial puncture is performed to get access to the epicardial space This allows placement of ablation catheters on the epicardial surface of the heart VT is induced and analysed from endo- and epicardial In addition to strategy 1 a 3D-reconstruction of the epicardial surface is made and scar areas are marked like from endocardial In a first step endocardial ablation is performed Thereafter changes in epicardial scar areas are analyzed In case of still inducible VT after endocardial ablation epicardial ablation is performed as a second step The success of strategy 1 and 2 is always checked by programmed ventricular stimulation
At least 12 months are planned for enrollment The study is closed if the patient last enrolled has completed the 12-months-follow up Follow up visits are scheduled at 3 6 and 12 months after the ablation procedure Recurrence of VT is monitored by ICD interrogation
Both ablation strategies are well established and conducted with standard equipment The methodology of this study does not contain any experimental approaches The standard insurance coverage of the hospital is guaranteed for all enrolled patients
The mechanism of most VTs are reentry circuits which are typically found in areas of scar in the left or right chamber These scar areas may be located in the inner layer of the myocardium endocardial in the outer layer epicardial or in all layers of the heart muscle transmural The standard ablation procedure is carried out from endocardial only This means catheters introduced through the femoral veins or arteries are placed in the right or left ventricle In 30 of patients treated this way a successful ablation is not possible In these cases the scar areas are mostly located in the outer layer of the myocardium Ablation is feasible only if the catheter is placed in the epicardial space to reach the surface of the heart muscle In the past this type of ablation was performed as a second procedure in case of recurrent VTs after unsuccessful endocardial ablation
This prospective randomized trial compares the standard ablation procedure endocardial ablation only with a new strategy This means in a single procedure the scar areas responsible for VT are marked and obliterated from endocardial as well as from epicardial The primary endpoint is recurrence of VT after endo- and epicardial vs endocardial ablation only
Patients are eligible if they show documented VT on the basis of an underlying cardiac disease and a therapy with antiarrhythmics was ineffective or not tolerated In terms of this study cardiac disease means CAD DCM and ARVC All patients have to be treated with an ICD Patients are not eligible if VT is not documented if there is no structural heart disease if they have a mechanical aortic valve or a pacemakerICD with epicardial leads implanted or if a pericardial puncture must not be done
40 patients will be enrolled They will be randomized 11 in the study arms strategy 1 which is standard endocardial ablation and strategy 2 which is endo- and epicardial ablation
In case of strategy 1 ablation catheters are placed in the right left or both ventricles through the femoral veinsarteries VT is induced by programmed stimulation and then analysed By means of 3D-electroanatomical mapping the endocardial surface is reconstructed The scar areas are marked and in a second step obliterated
In case of strategy 2 in addition to the endocardial access via femoral veinsarteries a pericardial puncture is performed to get access to the epicardial space This allows placement of ablation catheters on the epicardial surface of the heart VT is induced and analysed from endo- and epicardial In addition to strategy 1 a 3D-reconstruction of the epicardial surface is made and scar areas are marked like from endocardial In a first step endocardial ablation is performed Thereafter changes in epicardial scar areas are analyzed In case of still inducible VT after endocardial ablation epicardial ablation is performed as a second step The success of strategy 1 and 2 is always checked by programmed ventricular stimulation
At least 12 months are planned for enrollment The study is closed if the patient last enrolled has completed the 12-months-follow up Follow up visits are scheduled at 3 6 and 12 months after the ablation procedure Recurrence of VT is monitored by ICD interrogation
Both ablation strategies are well established and conducted with standard equipment The methodology of this study does not contain any experimental approaches The standard insurance coverage of the hospital is guaranteed for all enrolled patients
Study Oversight
Has Oversight DMC:
None
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?:
None