Trial Outcomes & Findings for PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing (NCT NCT00461734)
NCT ID: NCT00461734
Last Updated: 2017-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
248 participants
Primary outcome timeframe
At 2-year follow-up
Results posted on
2017-04-25
Participant Flow
Partecipants initially assessed for eligibility were 248 of whom 8 were excluded before the randomization due to the following causes: * 4 failed inclusion/exclusion criteria * 2 cheanged medical condition resulting no longer eligible * 1 had a non-pacemaker procedure * 1 the site was aware of his/her randomization code in the envelope
Participant milestones
| Measure |
RV Apex
RV lead placement site: Patients randomised to RV apical lead placement site
|
RV High Septum
RV lead placement site: Patients randomised to RV high septal lead placement site
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
62
|
60
|
|
Overall Study
NOT COMPLETED
|
58
|
60
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Baseline characteristics by cohort
| Measure |
RV Apex
n=120 Participants
RV lead placement site: Patients randomised to RV apical lead placement site
|
RV High Septum
n=120 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site
|
Total
n=240 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
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
95 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
74.7 years
STANDARD_DEVIATION 10 • n=107 Participants
|
74.2 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
12 participants
n=99 Participants
|
14 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
44 participants
n=99 Participants
|
42 participants
n=107 Participants
|
86 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
64 participants
n=99 Participants
|
64 participants
n=107 Participants
|
128 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 2-year follow-upPopulation: Intent to Treat Cohort with data available
Outcome measures
| Measure |
RV Apex
n=88 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=88 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
|
-2.29 percentage
Standard Deviation 10.5
|
-3.43 percentage
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: At 2-year follow-upPopulation: Per Protocol Cohort with data available
Outcome measures
| Measure |
RV Apex
n=89 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=59 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
|
-2.04 percentage
Standard Deviation 10.4
|
-3.60 percentage
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Intent to Treat Cohort with data available
Outcome measures
| Measure |
RV Apex
n=90 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=96 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
|
56.47 minutes per day
Standard Deviation 22.61
|
24.11 minutes per day
Standard Deviation 14.99
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Per Protocol Cohort with data available
Outcome measures
| Measure |
RV Apex
n=98 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=60 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
|
40.98 minutes per day
Standard Deviation 20.04
|
6.66 minutes per day
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: At 5-years follow-up (study extension)Population: Intent to Treat Cohort with data available
Outcome measures
| Measure |
RV Apex
n=50 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=58 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
|
17.73 minutes per day
Standard Deviation 11.95
|
63.83 minutes per day
Standard Deviation 36.82
|
SECONDARY outcome
Timeframe: At 5-year follow-up (study extension)Population: Per Protocol Cohort with data available
Outcome measures
| Measure |
RV Apex
n=59 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=32 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
|
62.75 minutes per day
Standard Deviation 36.21
|
18.61 minutes per day
Standard Deviation 16.61
|
SECONDARY outcome
Timeframe: At 5-year follow-up (study extension)Worsening of heart failure can be defined as: 1. Heart failure-related hospitalization requiring intravenous heart failure therapy, or 2. Emergency department visit for heart failure requiring intravenous heart failure therapy, or 3. Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction \<35%, and intravenous heart failure therapy is required or titrate therapy. 4. CRT-P or CRT-D upgrade.
Outcome measures
| Measure |
RV Apex
n=78 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=81 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Worsening of Heart Failure
|
19 episodes
|
17 episodes
|
SECONDARY outcome
Timeframe: At 5-year follow-up (study extension)Outcome measures
| Measure |
RV Apex
n=78 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=81 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
All Cause Mortality
|
14 participants
|
11 participants
|
SECONDARY outcome
Timeframe: At 5-year follow-up (study extension)Outcome measures
| Measure |
RV Apex
n=78 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=81 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Incidence of Stroke
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Intent to Treat Cohort with data available
Outcome measures
| Measure |
RV Apex
n=72 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=71 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
|
138.2 picograms per milliliter
Interval 0.3 to 1428.0
|
111.3 picograms per milliliter
Interval 0.3 to 1536.0
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Per Protocol Cohort with data available
Outcome measures
| Measure |
RV Apex
n=72 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=48 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
|
176.6 picograms per milliliter
Interval 0.3 to 1428.0
|
110.8 picograms per milliliter
Interval 0.3 to 1429.0
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: No analysis has been done for this section since that variable was not collected during the study
No analysis has been done for this section since that variable was not collected during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Intent to Treat Cohort with data available
Outcome measures
| Measure |
RV Apex
n=67 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=68 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
|
391 meters
Interval 307.0 to 475.0
|
395 meters
Interval 320.0 to 463.25
|
SECONDARY outcome
Timeframe: At 2-year follow-upPopulation: Per Protocol Cohort with data available
Outcome measures
| Measure |
RV Apex
n=68 Participants
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
|
RV High Septum
n=47 Participants
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
|
|---|---|---|
|
6 Minute Hall-Walk Distance (Per Protocol Cohort)
|
385.5 meters
Interval 304.5 to 477.5
|
426.5 meters
Interval 355.5 to 480.0
|
Adverse Events
RV Apex
Serious events: 78 serious events
Other events: 6 other events
Deaths: 0 deaths
RV High Septum
Serious events: 81 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RV Apex
n=120 participants at risk
RV lead placement site: Patients randomised to RV apical lead placement site
|
RV High Septum
n=120 participants at risk
RV lead placement site: Patients randomised to RV high septal lead placement site
|
|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
2.5%
3/120 • Number of events 3 • 5 years
|
2.5%
3/120 • Number of events 3 • 5 years
|
|
Cardiac disorders
SOB
|
20.8%
25/120 • Number of events 34 • 5 years
|
24.2%
29/120 • Number of events 50 • 5 years
|
|
Endocrine disorders
diabets
|
0.83%
1/120 • Number of events 1 • 5 years
|
1.7%
2/120 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
rectal bleeding
|
9.2%
11/120 • Number of events 12 • 5 years
|
5.8%
7/120 • Number of events 7 • 5 years
|
|
General disorders
chest pain
|
8.3%
10/120 • Number of events 13 • 5 years
|
7.5%
9/120 • Number of events 9 • 5 years
|
|
Hepatobiliary disorders
bile duct
|
1.7%
2/120 • Number of events 3 • 5 years
|
1.7%
2/120 • Number of events 2 • 5 years
|
|
Infections and infestations
infection
|
2.5%
3/120 • Number of events 3 • 5 years
|
0.83%
1/120 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
trauma
|
8.3%
10/120 • Number of events 10 • 5 years
|
16.7%
20/120 • Number of events 23 • 5 years
|
|
Investigations
angiography
|
1.7%
2/120 • Number of events 2 • 5 years
|
0.83%
1/120 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/120 • 5 years
|
0.83%
1/120 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
5.0%
6/120 • Number of events 9 • 5 years
|
5.0%
6/120 • Number of events 6 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinoma
|
6.7%
8/120 • Number of events 10 • 5 years
|
6.7%
8/120 • Number of events 15 • 5 years
|
|
Nervous system disorders
stroke
|
3.3%
4/120 • Number of events 8 • 5 years
|
7.5%
9/120 • Number of events 12 • 5 years
|
|
Renal and urinary disorders
urinary tract infection
|
4.2%
5/120 • Number of events 5 • 5 years
|
2.5%
3/120 • Number of events 3 • 5 years
|
|
Reproductive system and breast disorders
prostate
|
0.83%
1/120 • Number of events 1 • 5 years
|
1.7%
2/120 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
7.5%
9/120 • Number of events 11 • 5 years
|
6.7%
8/120 • Number of events 10 • 5 years
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
1.7%
2/120 • Number of events 2 • 5 years
|
0.83%
1/120 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
bypass
|
5.8%
7/120 • Number of events 10 • 5 years
|
4.2%
5/120 • Number of events 5 • 5 years
|
|
Vascular disorders
raynaud's disease
|
9.2%
11/120 • Number of events 12 • 5 years
|
6.7%
8/120 • Number of events 13 • 5 years
|
|
General disorders
death
|
15.8%
19/120 • Number of events 19 • 5 years
|
13.3%
16/120 • Number of events 16 • 5 years
|
|
Cardiac disorders
product issue
|
7.5%
9/120 • Number of events 9 • 5 years
|
9.2%
11/120 • Number of events 15 • 5 years
|
Other adverse events
| Measure |
RV Apex
n=120 participants at risk
RV lead placement site: Patients randomised to RV apical lead placement site
|
RV High Septum
n=120 participants at risk
RV lead placement site: Patients randomised to RV high septal lead placement site
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
5.0%
6/120 • Number of events 6 • 5 years
|
0.00%
0/120 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place