Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-22 @ 6:14 AM
Study NCT ID:
NCT01983293
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Cardiac Resynchronization Therapy (CRT) Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.
Status:
COMPLETED
Status Verified Date:
2019-02
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:
ENHANCE CRT
Brief Summary:
The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.
Detailed Description:
This is a prospective, pilot, multi-center, double-blinded, randomized post-market study to assess the effect of left ventricular lead pacing location (guided via QLV measurement vs. standard of care approach) in non-LBBB patients.
In the QLV arm the physician will:
1. Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
2. Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
3. Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
In the QLV arm the physician will:
1. Assess two branches of the coronary sinus - a non-traditional vessel (inclusive of the anterior region) will be tested first and a traditional free lateral branch will be tested second for LV lead placement.
2. Measure QLV for each of the four cathodes of the left ventricular lead in each branch.
3. Choose the vein branch and cathode with the longest QLV measurement and program a vector based on that cathode.
In the standard of care group, the left ventricular lead placement will be carried out according to the physician's standard of care implant approach.
The impact of the left ventricular lead position will be evaluated based on the patient's response to CRT utilizing the Clinical Composite Score (cardiovascular death, heart failure hospitalizations, New York Heart Association (NYHA) class, and Patient Global Assessment). Authorized site personnel conducting the NYHA class assessment and Patient Global Assessment will be blinded to the randomization assignment and lead implant technique.
Study Oversight
Has Oversight DMC:
False
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?: