Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157781
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2005-09-08
Brief Title:
LEAF - Low Energy In Atrial Fibrillation
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
Low Energy in Atrial Fibrillation AF Phase IV Study in ATAF Population Atrial Arrhythmias Prevention and Reduction With Low Energy Atrial Antitachycardia Pacemaker
Status:
COMPLETED
Status Verified Date:
2018-01
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 purpose of the study is to demonstrate the efficiency on AT AF prevention and termination of a new algorithm contained in the Medtronic AT500 Antitachycardia device in patients with conventional pacemaker indications
Detailed Description:
Aim More than 30 of patients pts implanted with a pacemaker are known to have atrial tachyarrhythmias AT despite medical treatment and about 20 of pts experience AT prior to implant The Medtronic AT500TM is a new DDDRP pacemaker with extended memory and features designed for preventing and terminating AT The objective of this European multi-center prospective crossover and randomized study is to evaluate efficacy of this device for decreasing AT burden improving QOL and reducing symptoms and costs Method 243 pts are implanted with the AT500TM and followed at 1 7 and 13 months after implant All patients are selected for a dual chamber pacemaker indication plus at least two episodes of AT in the last 12 months One month after implantation patients are randomized either to a six month therapy phase activation of preventive and ATP pacing or a six month observation phase No AT prevention nor Therapy Crossover CO takes place at seven months after implant and the endpoint is reached at 13 months Symptom checklist and QOL questionnaires are completed by pts at enrollment and after the two randomization periods At each follow-up a Save to Disk STD of device-stored AT episodes is performed and hospitalization visits andor other examinations are reported for future cost evaluation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 200108010 AFSSAPS France | None | None | None |
| CP0063 CCPPRB Lille France | None | None | None |