Trial Outcomes & Findings for Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial) (NCT NCT01169493)
NCT ID: NCT01169493
Last Updated: 2016-09-23
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
6 months
Results posted on
2016-09-23
Participant Flow
Participant milestones
| Measure |
VVI-40 to RV DDD-40 to Bi-V DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
VVI-40 to Bi-V DDD-40 to RV DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to VVI-40 to RV DDD-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to RV DDD-40 to VVI-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to VVI-40 to Bi-V DDD-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to Bi-V DDD-40 to VVI-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
|---|---|---|---|---|---|---|
|
Period 1 (6 Months)
STARTED
|
2
|
4
|
5
|
0
|
0
|
5
|
|
Period 1 (6 Months)
COMPLETED
|
2
|
3
|
3
|
0
|
0
|
2
|
|
Period 1 (6 Months)
NOT COMPLETED
|
0
|
1
|
2
|
0
|
0
|
3
|
|
Period 2 (6 Months)
STARTED
|
2
|
3
|
3
|
0
|
0
|
2
|
|
Period 2 (6 Months)
COMPLETED
|
2
|
3
|
3
|
0
|
0
|
2
|
|
Period 2 (6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (6 Months)
STARTED
|
2
|
3
|
3
|
0
|
0
|
2
|
|
Period 3 (6 Months)
COMPLETED
|
2
|
1
|
2
|
0
|
0
|
2
|
|
Period 3 (6 Months)
NOT COMPLETED
|
0
|
2
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
VVI-40 to RV DDD-40 to Bi-V DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
VVI-40 to Bi-V DDD-40 to RV DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to VVI-40 to RV DDD-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.
Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.
Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to RV DDD-40 to VVI-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to VVI-40 to Bi-V DDD-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to Bi-V DDD-40 to VVI-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
|---|---|---|---|---|---|---|
|
Period 1 (6 Months)
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
0
|
3
|
|
Period 3 (6 Months)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3 (6 Months)
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)
Baseline characteristics by cohort
| Measure |
VVI-40 to RV DDD-40 to Bi-V DDD-40
n=2 Participants
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
VVI-40 to Bi-V DDD-40 to RV DDD-40
n=4 Participants
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to VVI-40 to RV DDD-40
n=5 Participants
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Bi-V DDD-40 to RV DDD-40 to VVI-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to VVI-40 to Bi-V DDD-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
RV DDD-40 to Bi-V DDD-40 to VVI-40
n=5 Participants
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
VVI-40: Pacing mode set to VVI-40, RV only pacing
RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40
|
Total
n=16 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
|
—
|
—
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
—
|
—
|
2 participants
n=30 Participants
|
3 participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
—
|
—
|
3 participants
n=30 Participants
|
13 participants
n=3 Participants
|
|
Gender
Female
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
—
|
—
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
|
Gender
Male
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
—
|
—
|
5 participants
n=30 Participants
|
16 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.
|
0 percentage of participants
|
29 percentage of participants
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not collected.
Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.
To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
Arrhythmic Events
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.
This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
Minnesota Quality of Life Questionnaire
|
39.3 units on a scale
Standard Deviation 21.3
|
43.9 units on a scale
Standard Deviation 20.3
|
55.78 units on a scale
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.
6-minute walk distance was the distance that a participant could walk in 6 minutes.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
6-minute Walk Distance
|
292.4 meters
Standard Deviation 70.5
|
235.8 meters
Standard Deviation 122.8
|
244.44 meters
Standard Deviation 122
|
SECONDARY outcome
Timeframe: 6 monthsThe New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
NYHA Function Class
|
3.3 units on a scale
Standard Deviation 0.7
|
3 units on a scale
Standard Deviation 0.6
|
3.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not collected.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
|
24.8 percent
Standard Deviation 7.4
|
20 percent
Standard Deviation 9.7
|
22.9 percent
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not collected.
Outcome measures
| Measure |
VVI-40
n=10 Participants
The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
|
RV DDD-40
n=7 Participants
RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
|
Bi-V DDD-40
n=10 Participants
Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
|
|---|---|---|---|
|
Left Ventricular End-diastolic Size
|
203 cubic cm
Standard Error 39.9
|
236.6 cubic cm
Standard Error 27.1
|
236.5 cubic cm
Standard Error 54.6
|
Adverse Events
VVI-40
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RV DDD-40
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bi-V DDD-40
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VVI-40
n=11 participants at risk
VVI-40: Pacing mode set to VVI-40, RV only pacing
|
RV DDD-40
n=13 participants at risk
RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
|
Bi-V DDD-40
n=12 participants at risk
Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
|
|---|---|---|---|
|
Cardiac disorders
Heart Failure Exacerbation, Heart Transplant
|
0.00%
0/11 • Adverse event data was collected over 18 months
|
0.00%
0/13 • Adverse event data was collected over 18 months
|
16.7%
2/12 • Number of events 2 • Adverse event data was collected over 18 months
|
|
Infections and infestations
Death
|
0.00%
0/11 • Adverse event data was collected over 18 months
|
0.00%
0/13 • Adverse event data was collected over 18 months
|
0.00%
0/12 • Adverse event data was collected over 18 months
|
|
Cardiac disorders
Death
|
0.00%
0/11 • Adverse event data was collected over 18 months
|
0.00%
0/13 • Adverse event data was collected over 18 months
|
8.3%
1/12 • Number of events 1 • Adverse event data was collected over 18 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place