Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318130
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-02-06
Brief Title:
Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes
Status:
RECRUITING
Status Verified Date:
2024-01
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:
LEAD-LBP
Brief Summary:
This trial seeks to evaluate the performance of the extendable helix stylet-driven pacing lead SDL compared to the fixed helix lumenless pacing lead LLL during left bundle branch pacing LBBP with respect to enduring left bundle branch capture on follow-up incidence of acute lead failure pacing characteristics including QRS duration pacing thresholds R-wave amplitudes and lead impedance and finally safety profile during LBBP implantation These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance
Detailed Description:
This study is a single-blind randomised controlled trial aimed at evaluating the performance of the extendable helix stylet driven pacing lead SDL compared to the fixed helix lumenless pacing lead LLL during left bundle branch pacing LBBP The study is a multicentre study across 3 major hospitals in Singapore and LBBP performed by independent electrophysiologists experienced in performing LBBP
The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design LLL vs SDL The secondary objectives are to determine if lead design affects frequency of lead failure during implantation investigate differences in short- and medium-term LBBP parameters on follow-up by lead design and evaluate differences in safety profile between LLL and SDL in LBBP
This study aims to recruit a target of 210 patients A previous retrospective study found a loss of LB capture rate of 9 with LLL and 25 with SDL A sample size of 170 will be required for a type-1 error rate of 5 and power of 80 Accounting for a dropout rate of 20 a total of 210 patients will be recruited 105 per group Eligible subjects will be randomised to either the LLL or the SDL arm The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4 stratified by centre to ensure a final allocation ratio of 11
The primary objective of the study is to determine differences in incidence of loss of left bundle capture by pacing lead design LLL vs SDL The secondary objectives are to determine if lead design affects frequency of lead failure during implantation investigate differences in short- and medium-term LBBP parameters on follow-up by lead design and evaluate differences in safety profile between LLL and SDL in LBBP
This study aims to recruit a target of 210 patients A previous retrospective study found a loss of LB capture rate of 9 with LLL and 25 with SDL A sample size of 170 will be required for a type-1 error rate of 5 and power of 80 Accounting for a dropout rate of 20 a total of 210 patients will be recruited 105 per group Eligible subjects will be randomised to either the LLL or the SDL arm The randomisation list will be generated with a computer-generated sequence in permuted blocks of 4 stratified by centre to ensure a final allocation ratio of 11
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?:
False
Is an FDA AA801 Violation?:
None