Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228241
Status:
UNKNOWN
Last Update Posted:
2006-10-26
First Post:
2005-09-26
Brief Title:
Left Ventricular Function and Remodelling During Permanent Pacing
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Left Ventricular Function and Remodelling During Permanent Pacing
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
1 Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure New pacemaker types that stimulates both left and right ventricle biventricular pacemakers is introduced to the treatment of patients with heart failure decreased left ventricular function and ECG signs with left bundle branch block
2 Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function Biventricular pacing do not do this Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples This is not seen by biventricular pacing
3 Materials and methods - 3 studies All patients are examined by echocardiography 2-dimensional M-mode 3-dimensional and with tissue harmonic imaging Study 1 Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker Study 2 Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker Study 3 Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation
2 Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function Biventricular pacing do not do this Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples This is not seen by biventricular pacing
3 Materials and methods - 3 studies All patients are examined by echocardiography 2-dimensional M-mode 3-dimensional and with tissue harmonic imaging Study 1 Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker Study 2 Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker Study 3 Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation
Detailed Description:
None
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