Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02700425
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2016-01-29
Brief Title:
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
Status:
COMPLETED
Status Verified Date:
2021-07
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:
His-SYNC
Brief Summary:
The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle HB lead position versus with the standard coronary sinus CS lead position in subjects with heart failure undergoing cardiac resynchronization therapy CRT While placement of left ventricular leads via the coronary sinus has anatomic limitations we hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for improving systolic function by echocardiographic indices ejection fraction and strain and quality of life and decreased rehospitalization and mortality
Detailed Description:
This is a randomized single-blinded study of 40 patients to a strategy of HB pacing versus CS pacing and remain blinded to their treatment allocation Both treatment options use standard-of-care FDA-approved devices The distinction is only in the allocation toward HB pacing and CS pacing Treating physicians will be aware of assignment in order to facilitate routine device follow-up Echocardiographic and electrocardiographic evaluation will also be performed in a blinded manner
Cross-over is permitted between treatment group allocation if
CS lead cannot be placed due to difficult cannulation of the CS limited branches at the posterolateral or lateral wall or phrenic nerve capture These subjects may then cross-over to HB pacing
HB pacing subjects may cross-over if HB lead cannot be positioned with adequate stability and reasonable pacing output or if QRS width does not narrow by at least 20 or to a QRS width of 130 msec
Implant procedure will be per routine percutaneous access as is standard for pacemaker and ICDs All subjects will receive an FDA-approved cardiac resynchronization therapy pacemaker or defibrillator device as per standard of care outlined for the subject In order to facilitate optimal lead placement arterial access for levo-phase CS angiography andor LV septal mapping to characterize site of bundle-branch block may also be performed at the discretion of the implanting physician per hisher standard practice
Follow-up will be performed at 2 weeks post-implant for incision check and device interrogation as is standard of care In addition routine device and clinical follow-up will be scheduled at 1 3 6 and 12 months Electrocardiography ECG will be performed pre-implant prior to hospital discharge at 3 months 6 months and 12 months Echocardiography will be performed pre-implant and 6 months to evaluate for change in LVEF chamber dimension and wall motion with strain imaging as is standard of care in the treatment of patients with advanced heart failure NYHA functional class and quality of life utilizing the Kansas City Cardiomyopathy Questionnaire will be assessed pre-implant and at 6 months
Cross-over is permitted between treatment group allocation if
CS lead cannot be placed due to difficult cannulation of the CS limited branches at the posterolateral or lateral wall or phrenic nerve capture These subjects may then cross-over to HB pacing
HB pacing subjects may cross-over if HB lead cannot be positioned with adequate stability and reasonable pacing output or if QRS width does not narrow by at least 20 or to a QRS width of 130 msec
Implant procedure will be per routine percutaneous access as is standard for pacemaker and ICDs All subjects will receive an FDA-approved cardiac resynchronization therapy pacemaker or defibrillator device as per standard of care outlined for the subject In order to facilitate optimal lead placement arterial access for levo-phase CS angiography andor LV septal mapping to characterize site of bundle-branch block may also be performed at the discretion of the implanting physician per hisher standard practice
Follow-up will be performed at 2 weeks post-implant for incision check and device interrogation as is standard of care In addition routine device and clinical follow-up will be scheduled at 1 3 6 and 12 months Electrocardiography ECG will be performed pre-implant prior to hospital discharge at 3 months 6 months and 12 months Echocardiography will be performed pre-implant and 6 months to evaluate for change in LVEF chamber dimension and wall motion with strain imaging as is standard of care in the treatment of patients with advanced heart failure NYHA functional class and quality of life utilizing the Kansas City Cardiomyopathy Questionnaire will be assessed pre-implant and at 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None