Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157794
Status:
TERMINATED
Last Update Posted:
2017-02-15
First Post:
2005-09-09
Brief Title:
EnTRINSIC - EnPulse Trial on Search AV Influence
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
EnPulse Trial on Search AV Influence
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol pre-specified interim analysis showed that difference between groups was too small to reach significance
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular AV-conduction Recent findings demonstrate that pacing even might have unfavourable effects especially if patients suffer from additional cardiac diseases such as heart failure The Search AV algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation the amount of hospitalizations the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing
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