Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292383
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2006-02-14
Brief Title:
Ventricular Pacing Site Selection V-PASS
Sponsor:
Medtronic BRC
Organization:
Medtronic BRC
Study Overview
Official Title:
A Randomized Prospective Multicenter Pilot Study to Determine the Influence of the Ventricular Pacing Site on the Incidence of Atrial Fibrillation and Heart Failure in Patients With Indication for Permanent Pacemaker Stimulation Therapy
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
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:
The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation
Detailed Description:
AV-Block of higher degree is the primary indication for pacing therapy for about 20 of pacemaker patients Pacing systems with only ventricular stimulation VVI and VDD have a fraction of about 40 of all pacemakers in Germany About 50 of the implanted pacemakers in Germany are dual-chamber pacemakers and one half of them is used for treatment of AV blocks
Picture 1 Fractions of pacing indications in Germany Picture 2 Fractions of used pacing modes in Germany 1
A lot of studies proved in the past that the pacing site influenced the development of hemodynamics heart failure HF and atrial fibrillation AF Unfortunately the results are not commonly applicable or statistically assured Due to this further examinations are required in order to get explicit statements regarding application of alternative nonapical ventricular lead positioning
1 Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions either Group A Positioning at right ventricular apex or Group B Positioning at right ventricular high septum is feasible Included patients will already by examined and followed according to protocol After having proved feasibility of randomized positioning the data of these patients shall be used for evaluation of the V-PASS study
2 Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied
Picture 1 Fractions of pacing indications in Germany Picture 2 Fractions of used pacing modes in Germany 1
A lot of studies proved in the past that the pacing site influenced the development of hemodynamics heart failure HF and atrial fibrillation AF Unfortunately the results are not commonly applicable or statistically assured Due to this further examinations are required in order to get explicit statements regarding application of alternative nonapical ventricular lead positioning
1 Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions either Group A Positioning at right ventricular apex or Group B Positioning at right ventricular high septum is feasible Included patients will already by examined and followed according to protocol After having proved feasibility of randomized positioning the data of these patients shall be used for evaluation of the V-PASS study
2 Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied
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