Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-06
Brief Title:
Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Sponsor:
Kansas City Heart Rhythm Research Foundation
Organization:
Kansas City Heart Rhythm Research Foundation
Study Overview
Official Title:
Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
This a single-center retrospective observational study of patients that undergo coronary sinusCS lead revision comparing epicardial lead placement to coronary sinus pacingCSP in those that had lead failure
Detailed Description:
Cardiac resynchronization therapy with defibrillatorCRT-D improves quality of life functionality and even mortality for select patients with severe heart failure with reduced ejection fraction HFrEF It traditionally consists of three leads placed endovascularly into the right atrium right ventricle and left ventricle LV typically placed into the CS known as biventricular pacing resynchronization BVP-CRT respectively from which electrical stimulation enables improved cardiac synchrony Nonetheless the placement of a CRT-D is not without risks Lead-related complication is high and CRT-D implantation fails in up to 30 of patients due to lead placement alone
Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D It has even been shown to be options in patients that fail conventional BVP-CRT This is primarily due to increased accuracy decreased complications and even durability However guidelines for decision between a transthoracic approach and CSP is unclear even more so after lead failure Instead this decision is currently individualized to the patient There is a lack of prospective and head-to-head data between the two and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT
Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D It has even been shown to be options in patients that fail conventional BVP-CRT This is primarily due to increased accuracy decreased complications and even durability However guidelines for decision between a transthoracic approach and CSP is unclear even more so after lead failure Instead this decision is currently individualized to the patient There is a lack of prospective and head-to-head data between the two and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None