Trial Outcomes & Findings for HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy (NCT NCT04561778)
NCT ID: NCT04561778
Last Updated: 2024-08-07
Results Overview
Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
6 months
Results posted on
2024-08-07
Participant Flow
Subjects will be recruited from Geisinger Wyoming Valley, Geisinger Medical Center, and Geisinger Community Medical Center. Investigators will identify eligible subjects, describe the study procedures and invite them to participate in the study. Informed Consent (ICF) will be provided to the subject and they will have ample time and opportunity to review and consider participation. Prior to performing any study procedures, the subject will sign the ICF and be considered enrolled at that point.
Subjects were screened to meet inclusion/exclusion criteria pre consent and post consent, pre implant. In some cases, a repeat echo was scheduled to obtain ejection fraction (EF) measurement as part of inclusion/exclusion criteria, and result was pending at time of consent, therefore when resulted and patient no longer met inclusion criteria, they were screen failed.
Participant milestones
| Measure |
BiV Pacing
Patients randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches
|
HOT-CRT
Patients randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular (LV) timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Cross Over to HOTCRT
|
9
|
0
|
|
Overall Study
Cross Over to BiV
|
0
|
2
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
HOT-CRT
n=50 Participants
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=50 Participants
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
All patients
|
71 years
STANDARD_DEVIATION 13.4 • n=50 Participants
|
68.9 years
STANDARD_DEVIATION 11.5 • n=50 Participants
|
70 years
STANDARD_DEVIATION 12.5 • n=100 Participants
|
|
Sex: Female, Male
All patients · Female
|
11 Participants
n=50 Participants
|
20 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Sex: Female, Male
All patients · Male
|
39 Participants
n=50 Participants
|
30 Participants
n=50 Participants
|
69 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Hypertension
|
42 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
80 Participants
n=100 Participants
|
|
Diabetes
|
26 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
49 Participants
n=100 Participants
|
|
Coronary Artery Disease
|
23 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
45 Participants
n=100 Participants
|
|
Atrial fibrillation
|
12 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
34 Participants
n=100 Participants
|
|
Chronic kidney disease
|
17 Participants
n=50 Participants
|
18 Participants
n=50 Participants
|
35 Participants
n=100 Participants
|
|
Nonischemic cardiomyopathy
|
30 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
61 Participants
n=100 Participants
|
|
Left bundle branch block
|
31 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
62 Participants
n=100 Participants
|
|
Left ventricular ejection fraction
|
30.1 percent ejection fraction
STANDARD_DEVIATION 9.1 • n=50 Participants
|
30.7 percent ejection fraction
STANDARD_DEVIATION 9.3 • n=50 Participants
|
30.4 percent ejection fraction
STANDARD_DEVIATION 9.1 • n=100 Participants
|
|
QRS
|
164 ms
STANDARD_DEVIATION 26 • n=50 Participants
|
166 ms
STANDARD_DEVIATION 28 • n=50 Participants
|
165.0 ms
STANDARD_DEVIATION 26.5 • n=100 Participants
|
|
New York Heart Association (NYHA) functional class
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=50 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=50 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.7 • n=100 Participants
|
|
Medications
Beta blocker
|
45 Participants
n=50 Participants
|
47 Participants
n=50 Participants
|
92 Participants
n=100 Participants
|
|
Medications
Aldosterone antagonist
|
14 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
29 Participants
n=100 Participants
|
|
Medications
Amiodarone
|
9 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
17 Participants
n=100 Participants
|
|
Medications
ACE
|
22 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
35 Participants
n=100 Participants
|
|
Medications
ARB
|
10 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
15 Participants
n=100 Participants
|
|
Medications
ARNI
|
11 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
25 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline
Outcome measures
| Measure |
HOT-CRT
n=50 Participants
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=50 Participants
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
|---|---|---|
|
Primary Endpoint
|
12.4 percent ejection fraction
Standard Deviation 7.3
|
8.0 percent ejection fraction
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
Freedom from major complications or need for CRT lead revision - complication such as lead dislodgment, pericardial tamponade, pneumothorax, systemic embolism, phrenic nerve stimulation not correctable by programming
Outcome measures
| Measure |
HOT-CRT
n=50 Participants
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=50 Participants
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
|---|---|---|
|
Primary Safety
|
49 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
Crossover, ventricular tachycardia (VT)/ventricular fibrillation (VF), Heart failure hospitalization (HFH) or death
Outcome measures
| Measure |
HOT-CRT
n=50 Participants
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=50 Participants
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
|---|---|---|
|
Secondary Composite
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
change in LVEF \>5%
Outcome measures
| Measure |
HOT-CRT
n=50 Participants
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=50 Participants
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
|---|---|---|
|
Echocardiographic Response
|
35 Participants
|
27 Participants
|
Adverse Events
HOT-CRT
Serious events: 17 serious events
Other events: 0 other events
Deaths: 2 deaths
Biventricular Pacing
Serious events: 32 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
HOT-CRT
n=57 participants at risk
Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.
HOT-CRT: Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
|
Biventricular Pacing
n=43 participants at risk
Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.
Biventricular Pacing: Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
|
|---|---|---|
|
Cardiac disorders
Threshold increase >1 V
|
3.5%
2/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
9.3%
4/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Lead dislodgement
|
5.3%
3/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
4.7%
2/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Stroke
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
0.00%
0/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Infections and infestations
Infection
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
2.3%
1/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Late perforation into left ventricle
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
0.00%
0/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
0.00%
0/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Phrenic nerve stimulation
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
9.3%
4/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Surgical and medical procedures
Hematoma requiring evacuation
|
0.00%
0/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
2.3%
1/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Secondary composite clinical endpoint
|
18.0%
9/50 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
32.6%
14/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
|
Cardiac disorders
Total
|
5.3%
3/57 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
23.3%
10/43 • Adverse events (AE) were monitored through the patient's study participation (about 6 months) and throughout the course of the study.
An AE includes, but is not limited to, the following: Any clinically significant worsening of a preexisting condition. An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. An AE that has been associated with the discontinuation of the use of a test article. 50 patients randomized to BiV - 43 received BiV treatment 50 patients randomized to HOTCRT - 57 received HOTCRT treatment
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place