Trial Outcomes & Findings for His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy (NCT NCT02700425)
NCT ID: NCT02700425
Last Updated: 2021-09-05
Results Overview
Change in left ventricular ejection fraction (LVEF) as measured by echocardiography in a blinded core lab.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2021-09-05
Participant Flow
Participant milestones
| Measure |
His Bundle Pacing
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
Baseline characteristics by cohort
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
PR interval (PR)
|
186 ms
n=99 Participants
|
184 ms
n=107 Participants
|
186 ms
n=206 Participants
|
|
QRS interval (QRS)
|
172 seconds
STANDARD_DEVIATION 16 • n=99 Participants
|
165 seconds
STANDARD_DEVIATION 18 • n=107 Participants
|
168 seconds
STANDARD_DEVIATION 18 • n=206 Participants
|
|
QTc
|
484 ms
STANDARD_DEVIATION 48 • n=99 Participants
|
478 ms
STANDARD_DEVIATION 35 • n=107 Participants
|
481 ms
STANDARD_DEVIATION 42 • n=206 Participants
|
|
Left Ventricular end-diastolic volume (LVEDV)
|
220 mL
n=99 Participants
|
190 mL
n=107 Participants
|
201 mL
n=206 Participants
|
|
Left Ventricular End-Systolic Volume (LVESV)
|
165 mL
n=99 Participants
|
126 mL
n=107 Participants
|
148 mL
n=206 Participants
|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
63.8 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African-American
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
19 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Height
|
172.4 cm
STANDARD_DEVIATION 9.6 • n=99 Participants
|
166.5 cm
STANDARD_DEVIATION 13.3 • n=107 Participants
|
169.6 cm
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Weight
|
88.0 kg
n=99 Participants
|
78.0 kg
n=107 Participants
|
83.5 kg
n=206 Participants
|
|
Body Mass Index (BMI)
|
29.4 kg/m^2
n=99 Participants
|
29.4 kg/m^2
n=107 Participants
|
29.4 kg/m^2
n=206 Participants
|
|
Hypertension (HTN)
Hypertension
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Hypertension (HTN)
No Hypertension
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
CAD
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
No CAD
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
History of Coronary-Artery Bypass Graft (CABG)
CABG
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
History of Coronary-Artery Bypass Graft (CABG)
No CABG
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
History of Atrial Fibrillation (AF)
AF
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
History of Atrial Fibrillation (AF)
No AF
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
COPD
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
No COPD
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Diabetes Mellitus Type 2 (DM2)
DM
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Diabetes Mellitus Type 2 (DM2)
No DM
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Chronic Kidney Disease (CKD)
CKD
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Chronic Kidney Disease (CKD)
No CKD
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
End-Stage Renal Disease (ESRD)
ESRD
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
End-Stage Renal Disease (ESRD)
No ESRD
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
End-Stage Renal Disease (ESRD)
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
New York Heart Association (NYHA) Class
|
3.0 stages
n=99 Participants
|
2.5 stages
n=107 Participants
|
3.0 stages
n=206 Participants
|
|
Beta-blocker (BB)
BB
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Beta-blocker (BB)
No BB
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Angiotensin-converting enzyme inhibitor (ACE-I)
ACE-I
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Angiotensin-converting enzyme inhibitor (ACE-I)
No ACE-I
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Angiotensin II Receptor Blocker (ARB)
ARB
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Angiotensin II Receptor Blocker (ARB)
No ARB
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Angiotensin II Recptor Blocker (ARB)/neprilysin inhibitor
ARB/neprilysin inhibitor
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Angiotensin II Recptor Blocker (ARB)/neprilysin inhibitor
No ARB/neprilysin inhibitor
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Amiodarone
Amiodarone
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Amiodarone
No Amiodarone
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Digoxin
Digoxin
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Digoxin
No Digoxin
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Spironolactone
Spironolactone
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Spironolactone
No Spironolactone
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
26.3 percent of ejection fraction
n=99 Participants
|
30.5 percent of ejection fraction
n=107 Participants
|
27.8 percent of ejection fraction
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Change in left ventricular ejection fraction (LVEF) as measured by echocardiography in a blinded core lab.
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction (LVEF)
6-months
|
31.9 ejection fraction percentage
Interval 30.8 to 40.1
|
34.0 ejection fraction percentage
Interval 31.6 to 42.1
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
Baseline
|
26.3 ejection fraction percentage
Interval 21.3 to 28.3
|
30.5 ejection fraction percentage
Interval 27.1 to 33.9
|
PRIMARY outcome
Timeframe: baseline and 12 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Change in QRS duration as measured by electrocardiography
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Change in QRS Duration
Baseline
|
172 ms
Standard Deviation 16
|
165 ms
Standard Deviation 19
|
|
Change in QRS Duration
1-year
|
144 ms
Standard Deviation 30
|
152 ms
Standard Deviation 30
|
PRIMARY outcome
Timeframe: Through study completion, an average of 12 months.Population: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Time to first cardiovascular hospitalization or death in months
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Time to First Cardiovascular Hospitalization or Death
|
10.63 months
Interval 8.47 to 12.0
|
11.58 months
Interval 8.3 to 12.0
|
SECONDARY outcome
Timeframe: baseline, 6 months, and 12 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis. NYHA class determines the functional status of the patient. There are classes I-IV. Class I is no symptoms and IV is symptoms at rest.
New York Heart Association (NYHA) functional class change for baseline, 6 months, and 12 months. NYHA class determines the functional status of the patient. There are classes I-IV. Class I is no symptoms or limitation of physical activity, II is slight limitation of physical activity but comfortable at rest, III marked limitation of physical activity, and IV is unable to carry any physical activity without discomfort, heart failure symptoms at rest, and discomfort increases with any physical activity as described the American Heart Association (AHA).
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
New York Heart Association (NYHA) Functional Class Change
Baseline
|
3.0 class grade
Interval 2.5 to 3.0
|
2.5 class grade
Interval 2.0 to 3.0
|
|
New York Heart Association (NYHA) Functional Class Change
6-Months
|
2.0 class grade
Interval 2.0 to 2.5
|
2.0 class grade
Interval 1.0 to 2.0
|
|
New York Heart Association (NYHA) Functional Class Change
1-Year
|
3.0 class grade
Interval 2.0 to 3.0
|
2.0 class grade
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Quality of life change as measured by Kansas City Questionnaire (KCCQ) is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from minimum of 0-100 (maximum); higher scores show better health status. Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Quality of Life Change by Kansas City Questionnaire (KCCQ)
Baseline
|
65 score on a scale
Interval 37.0 to 86.0
|
70 score on a scale
Interval 42.0 to 83.0
|
|
Quality of Life Change by Kansas City Questionnaire (KCCQ)
1-Year
|
44 score on a scale
Interval 40.0 to 93.0
|
85 score on a scale
Interval 82.0 to 93.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 12 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Time to first cardiovascular rehospitalization in 12 months
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
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Time to First Cardiovascular Rehospitalization
|
10.63 months
Interval 8.47 to 12.0
|
11.58 months
Interval 8.3 to 12.0
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SECONDARY outcome
Timeframe: Through study completion, an average of 12 monthsPopulation: All analyses shown are intention-to-treat. Of note, 5 patients from Coronary Sinus Pacing crossed over to His Bundle Pacing, but were analyzed Coronary Sinus Pacing. Likewise, 10 patients from His Bundle Pacing crossed over to the Coronary Sinus Pacing, but they were analyzed as His Bundle Pacing under intention-to-treat analysis.
Time to first treated ventricular arrhythmia/ventricular tachycardia (VT/VF) in 12 months
Outcome measures
| Measure |
His Bundle Pacing
n=21 Participants
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 Participants
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF)
|
10.63 months
Interval 8.57 to 12.0
|
11.58 months
Interval 6.97 to 12.0
|
Adverse Events
His Bundle Pacing
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Coronary Sinus Pacing
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
His Bundle Pacing
n=21 participants at risk；n=16 participants at risk
Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
Coronary Sinus Pacing
n=19 participants at risk；n=24 participants at risk
Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.
CRT Pacemaker: Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
|
|---|---|---|
|
Nervous system disorders
Transient ischemic attack with aphasia
|
0.00%
0/21 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
|
Surgical and medical procedures
atrial lead microdislodgment
|
0.00%
0/21 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
|
Skin and subcutaneous tissue disorders
hematoma
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
0.00%
0/19 • Adverse event data were collected over 1 year.
Adverse events were required to be systematically reported into REDCap at time of procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place