Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157846
Status:
TERMINATED
Last Update Posted:
2017-02-15
First Post:
2005-09-09
Brief Title:
X-Change HF - Exchange of the Existing PacemakerICD in Bradycardia Patients Suffering From Heart Failure
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
Exchange of the Existing PacemakerICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to existing evidence eligible patients receive CRT treatment in first place
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation more than 80 are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator ICD and have ventricular dysfunction left ventricular ejection fraction LVEF 35 All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy CRT-device and receive either right ventricular or biventricular stimulation in a crossover protocol The endpoint is functional performance measured by spiroergometry
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