Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-28 @ 12:34 PM
Study NCT ID:
NCT01535404
Status:
TERMINATED
Last Update Posted:
2016-05-13
First Post:
2012-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function Study
Sponsor:
Haran Burri, MD
Organization:
Study Overview
Official Title:
Right Versus Left Apical Transvenous Pacing for Patients With Preserved Left Ventricular Systolic Function (RIVELA) Study
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIVELA
Brief Summary:
The purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (RVA) versus the left ventricular apex (LVA) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).
Detailed Description:
It is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. An alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the RVA in small series. The left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). Our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3D-echocardiography.
Study Oversight
Has Oversight DMC:
True
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?: