Congestive Heart Failure
Conditions
Keywords
Wide QRS, Ventricular Dyssynchrony
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 and/or LV septal mapping to characterize site of bundle-branch block may also be performed, at the discretion of the implanting physician per his/her 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.
Interventions
DEVICECRT 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.
Sponsors
University of California, Los Angeles
Northwestern University
Rush University Medical Center
Geisinger Clinic
Indiana University
Edward Hospital
Baptist Health, Louisville
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age * LV systolic dysfunction with LVEF ≤ 35% * Evidence of intraventricular conduction delay with QRS duration \> 120 msec * NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy * Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm (SR), left bundle-branch block (LBBB) morphology, and QRS duration ≥ 150 msec, and NYHA Class II, III, or ambulatory Class IV patients on goal-directed medical therapy (GDMT) \[Class I\] * LVEF ≤ 35%, SR with LBBB with QRS 120-149 msec on GDMT \[Class IIa\] * LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec on GDMT \[Class IIa\] * LVEF ≤ 35%, in AF if medication or AV nodal ablation will allow near 100% pacing \[Class IIa\] * LVEF ≤ 35% undergoing new or replacement device with anticipated \>40% ventricular pacing on GDMT \[Class IIa\] * LVEF ≤ 30%, ischemic etiology of HF, SR with LBBB ≥ 150 msec and NYHA Class I symptoms on GDMT \[Class IIb\] * LVEF ≤ 35%, SR with non-LBBB with QRS 120-149 msec, NYHA Class III/ambulatory Class IV HF on GDMT \[Class IIb\] LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec, NYHA Class II HF on GDMT \[Class IIb\]
Exclusion criteria
* Existing CRT device * Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity * Pregnancy * Participation in other trials * Difficulty with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | baseline and 6 months | Change in left ventricular ejection fraction (LVEF) as measured by echocardiography in a blinded core lab. |
| Change in QRS Duration | baseline and 12 months | Change in QRS duration as measured by electrocardiography |
| Time to First Cardiovascular Hospitalization or Death | Through study completion, an average of 12 months. | Time to first cardiovascular hospitalization or death in months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA) Functional Class Change | baseline, 6 months, and 12 months | 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). |
| Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF) | Through study completion, an average of 12 months | Time to first treated ventricular arrhythmia/ventricular tachycardia (VT/VF) in 12 months |
| Quality of Life Change by Kansas City Questionnaire (KCCQ) | baseline and 12 months | 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. |
| Time to First Cardiovascular Rehospitalization | Through study completion, an average of 12 months | Time to first cardiovascular rehospitalization in 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | His Bundle Pacing | Total | Coronary Sinus Pacing |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 11.4 | 64.6 years STANDARD_DEVIATION 12.6 | 63.8 years STANDARD_DEVIATION 14.1 |
| Amiodarone Amiodarone | 4 Participants | 8 Participants | 4 Participants |
| Amiodarone No Amiodarone | 17 Participants | 32 Participants | 15 Participants |
| Angiotensin-converting enzyme inhibitor (ACE-I) ACE-I | 5 Participants | 11 Participants | 6 Participants |
| Angiotensin-converting enzyme inhibitor (ACE-I) No ACE-I | 16 Participants | 29 Participants | 13 Participants |
| Angiotensin II Receptor Blocker (ARB) ARB | 5 Participants | 10 Participants | 5 Participants |
| Angiotensin II Receptor Blocker (ARB) No ARB | 16 Participants | 30 Participants | 14 Participants |
| Angiotensin II Recptor Blocker (ARB)/neprilysin inhibitor ARB/neprilysin inhibitor | 5 Participants | 9 Participants | 4 Participants |
| Angiotensin II Recptor Blocker (ARB)/neprilysin inhibitor No ARB/neprilysin inhibitor | 16 Participants | 31 Participants | 15 Participants |
| Beta-blocker (BB) BB | 21 Participants | 39 Participants | 18 Participants |
| Beta-blocker (BB) No BB | 0 Participants | 1 Participants | 1 Participants |
| Body Mass Index (BMI) | 29.4 kg/m^2 | 29.4 kg/m^2 | 29.4 kg/m^2 |
| Chronic Kidney Disease (CKD) CKD | 10 Participants | 19 Participants | 9 Participants |
| Chronic Kidney Disease (CKD) No CKD | 11 Participants | 21 Participants | 10 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) COPD | 4 Participants | 10 Participants | 6 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) No COPD | 17 Participants | 30 Participants | 13 Participants |
| Coronary Artery Disease (CAD) CAD | 13 Participants | 26 Participants | 13 Participants |
| Coronary Artery Disease (CAD) No CAD | 8 Participants | 14 Participants | 6 Participants |
| Diabetes Mellitus Type 2 (DM2) DM | 11 Participants | 19 Participants | 8 Participants |
| Diabetes Mellitus Type 2 (DM2) No DM | 10 Participants | 21 Participants | 11 Participants |
| Digoxin Digoxin | 2 Participants | 6 Participants | 4 Participants |
| Digoxin No Digoxin | 19 Participants | 34 Participants | 15 Participants |
| End-Stage Renal Disease (ESRD) ESRD | 1 Participants | 3 Participants | 2 Participants |
| End-Stage Renal Disease (ESRD) No ESRD | 19 Participants | 36 Participants | 17 Participants |
| End-Stage Renal Disease (ESRD) Unknown | 1 Participants | 1 Participants | 0 Participants |
| Height | 172.4 cm STANDARD_DEVIATION 9.6 | 169.6 cm STANDARD_DEVIATION 11.7 | 166.5 cm STANDARD_DEVIATION 13.3 |
| History of Atrial Fibrillation (AF) AF | 8 Participants | 13 Participants | 5 Participants |
| History of Atrial Fibrillation (AF) No AF | 13 Participants | 27 Participants | 14 Participants |
| History of Coronary-Artery Bypass Graft (CABG) CABG | 5 Participants | 7 Participants | 2 Participants |
| History of Coronary-Artery Bypass Graft (CABG) No CABG | 16 Participants | 33 Participants | 17 Participants |
| Hypertension (HTN) Hypertension | 16 Participants | 30 Participants | 14 Participants |
| Hypertension (HTN) No Hypertension | 5 Participants | 10 Participants | 5 Participants |
| Left Ventricular Ejection Fraction (LVEF) | 26.3 percent of ejection fraction | 27.8 percent of ejection fraction | 30.5 percent of ejection fraction |
| Left Ventricular end-diastolic volume (LVEDV) | 220 mL | 201 mL | 190 mL |
| Left Ventricular End-Systolic Volume (LVESV) | 165 mL | 148 mL | 126 mL |
| New York Heart Association (NYHA) Class | 3.0 stages | 3.0 stages | 2.5 stages |
| PR interval (PR) | 186 ms | 186 ms | 184 ms |
| QRS interval (QRS) | 172 seconds STANDARD_DEVIATION 16 | 168 seconds STANDARD_DEVIATION 18 | 165 seconds STANDARD_DEVIATION 18 |
| QTc | 484 ms STANDARD_DEVIATION 48 | 481 ms STANDARD_DEVIATION 42 | 478 ms STANDARD_DEVIATION 35 |
| Race/Ethnicity, Customized African-American | 7 Participants | 12 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 25 Participants | 12 Participants |
| Region of Enrollment United States | 21 participants | 40 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 25 Participants | 11 Participants |
| Spironolactone No Spironolactone | 14 Participants | 26 Participants | 12 Participants |
| Spironolactone Spironolactone | 7 Participants | 14 Participants | 7 Participants |
| Weight | 88.0 kg | 83.5 kg | 78.0 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 21 | 1 / 19 |
| other Total, other adverse events | 1 / 21 | 3 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 24 |
Outcome results
Primary
Change in Left Ventricular Ejection Fraction (LVEF)
Change in left ventricular ejection fraction (LVEF) as measured by echocardiography in a blinded core lab.
Time frame: baseline and 6 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| His Bundle Pacing | Change in Left Ventricular Ejection Fraction (LVEF) | Baseline | 26.3 ejection fraction percentage |
| His Bundle Pacing | Change in Left Ventricular Ejection Fraction (LVEF) | 6-months | 31.9 ejection fraction percentage |
| Coronary Sinus Pacing | Change in Left Ventricular Ejection Fraction (LVEF) | Baseline | 30.5 ejection fraction percentage |
| Coronary Sinus Pacing | Change in Left Ventricular Ejection Fraction (LVEF) | 6-months | 34.0 ejection fraction percentage |
Comparison: The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.p-value: <0.001Sign test
Comparison: The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.p-value: <0.001Sign test
Primary
Change in QRS Duration
Change in QRS duration as measured by electrocardiography
Time frame: baseline and 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| His Bundle Pacing | Change in QRS Duration | Baseline | 172 ms | Standard Deviation 16 |
| His Bundle Pacing | Change in QRS Duration | 1-year | 144 ms | Standard Deviation 30 |
| Coronary Sinus Pacing | Change in QRS Duration | Baseline | 165 ms | Standard Deviation 19 |
| Coronary Sinus Pacing | Change in QRS Duration | 1-year | 152 ms | Standard Deviation 30 |
Comparison: Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.p-value: 0.002t-test, 2 sided
Comparison: Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.p-value: 0.002t-test, 2 sided
Primary
Time to First Cardiovascular Hospitalization or Death
Time to first cardiovascular hospitalization or death in months
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| His Bundle Pacing | Time to First Cardiovascular Hospitalization or Death | 10.63 months |
| Coronary Sinus Pacing | Time to First Cardiovascular Hospitalization or Death | 11.58 months |
Comparison: Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.p-value: 0.62Log Rank
Secondary
New York Heart Association (NYHA) Functional Class Change
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).
Time frame: baseline, 6 months, and 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. 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| His Bundle Pacing | New York Heart Association (NYHA) Functional Class Change | Baseline | 3.0 class grade |
| His Bundle Pacing | New York Heart Association (NYHA) Functional Class Change | 6-Months | 2.0 class grade |
| His Bundle Pacing | New York Heart Association (NYHA) Functional Class Change | 1-Year | 3.0 class grade |
| Coronary Sinus Pacing | New York Heart Association (NYHA) Functional Class Change | Baseline | 2.5 class grade |
| Coronary Sinus Pacing | New York Heart Association (NYHA) Functional Class Change | 6-Months | 2.0 class grade |
| Coronary Sinus Pacing | New York Heart Association (NYHA) Functional Class Change | 1-Year | 2.0 class grade |
Comparison: NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.p-value: 0.09Sign test
Comparison: NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.p-value: 0.32Sign test
Secondary
Quality of Life Change by Kansas City Questionnaire (KCCQ)
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.
Time frame: baseline and 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| His Bundle Pacing | Quality of Life Change by Kansas City Questionnaire (KCCQ) | Baseline | 65 score on a scale |
| His Bundle Pacing | Quality of Life Change by Kansas City Questionnaire (KCCQ) | 1-Year | 44 score on a scale |
| Coronary Sinus Pacing | Quality of Life Change by Kansas City Questionnaire (KCCQ) | Baseline | 70 score on a scale |
| Coronary Sinus Pacing | Quality of Life Change by Kansas City Questionnaire (KCCQ) | 1-Year | 85 score on a scale |
Comparison: Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.p-value: 0.35Sign test
Comparison: Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.p-value: 0.07Sign test
Secondary
Time to First Cardiovascular Rehospitalization
Time to first cardiovascular rehospitalization in 12 months
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| His Bundle Pacing | Time to First Cardiovascular Rehospitalization | 10.63 months |
| Coronary Sinus Pacing | Time to First Cardiovascular Rehospitalization | 11.58 months |
Comparison: Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.p-value: 0.14Log Rank
Secondary
Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF)
Time to first treated ventricular arrhythmia/ventricular tachycardia (VT/VF) in 12 months
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| His Bundle Pacing | Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF) | 10.63 months |
| Coronary Sinus Pacing | Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF) | 11.58 months |
Comparison: Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.p-value: 0.14Log Rank