Trial Outcomes & Findings for Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial) (NCT NCT02441101)
NCT ID: NCT02441101
Last Updated: 2024-06-18
Results Overview
LV Ejection Fraction is defined as \[(end diastolic volume minus end systolic volume) / (end diastolic volume\] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
RV Pacing Optimization on First, Then Off
Arm 1 is RV pacing optimization on first, then off
After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned on for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned off for 3 months and final outcome measurements are performed. This is a crossover study.
|
RV Pacing Optimization Off First, Then on
Arm 2 is RV pacing optimization off first then on
After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned off for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned on for 3 months and final outcome measurements are performed. This is a crossover study.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
RV Pacing Optimization on First, Then Off
Arm 1 is RV pacing optimization on first, then off
After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned on for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned off for 3 months and final outcome measurements are performed. This is a crossover study.
|
RV Pacing Optimization Off First, Then on
Arm 2 is RV pacing optimization off first then on
After baseline measurements, RV DDD(R)-60 with AV optimization (Device is programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG) is turned off for 3 months. After the outcome measurements, RV DDD(R)-60 with AV optimization is turned on for 3 months and final outcome measurements are performed. This is a crossover study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
PI relocated and study terminated
|
1
|
0
|
Baseline Characteristics
Right Ventricular Septal Pacing in Patients With Right Bundle Branch Block and Heart Failure (The SPARK Trial)
Baseline characteristics by cohort
| Measure |
RV Pacing Optimization on First, Then Off
n=4 Participants
RV Pacing Optimization on first, then Off
RV DDD(R)-60 with AV optimization: Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
|
RV Pacing Optimization Off First, Then on
n=2 Participants
RV Pacing Optimization off first, then on
RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 9 • n=99 Participants
|
62 years
STANDARD_DEVIATION 15 • n=107 Participants
|
70 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsLV Ejection Fraction is defined as \[(end diastolic volume minus end systolic volume) / (end diastolic volume\] as measured by echocardiography. Comparison of LV Ejection Fraction with RV pacing optimization on vs. RV pacing optimization off. Arm 1 is RV pacing optimization on then off Arm 2 is RV pacing optimization off then on
Outcome measures
| Measure |
RV Pacing Optimization on
n=6 Participants
Arm 1 is RV pacing optimization on
RV DDD(R)-60 with AV optimization: Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
|
RV Pacing Optimization Off
n=3 Participants
Arm 2 is RV pacing optimization off
RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming.
|
|---|---|---|
|
Change of LV Ejection Fraction Compared to Baseline
|
0 Percent
Standard Deviation 4
|
4 Percent
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsComparing baseline to intervention on Comparing intervention off to intervention off Expect statistically significant decrease with intervention on
Outcome measures
| Measure |
RV Pacing Optimization on
n=6 Participants
Arm 1 is RV pacing optimization on
RV DDD(R)-60 with AV optimization: Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
|
RV Pacing Optimization Off
n=3 Participants
Arm 2 is RV pacing optimization off
RV DDD(R)-60: AV settings programmed to minimize RV pacing - standard demand pacing programming.
|
|---|---|---|
|
Electrocardiographic: QRS Duration
|
-36 Milliseconds
Standard Deviation 22
|
2 Milliseconds
Standard Deviation 9
|
Adverse Events
RV Pacing Optimization on
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RV Pacing Optimization Off
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place