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PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing (PROTECT-PACE)

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ClinicalTrials.gov Identifier: NCT00461734
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Left Ventricular Dysfunction
Intervention Other: RV lead placement site
Enrollment 248
Recruitment Details  
Pre-assignment Details

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
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description RV lead placement site: Patients randomised to RV apical lead placement site RV lead placement site: Patients randomised to RV high septal lead placement site
Period Title: Overall Study
Started 120 120
Completed 62 60
Not Completed 58 60
Arm/Group Title RV Apex RV High Septum Total
Hide Arm/Group Description RV lead placement site: Patients randomised to RV apical lead placement site RV lead placement site: Patients randomised to RV high septal lead placement site Total of all reporting groups
Overall Number of Baseline Participants 120 120 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  20.8%
19
  15.8%
44
  18.3%
>=65 years
95
  79.2%
101
  84.2%
196
  81.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 120 participants 240 participants
73.7  (11.1) 74.7  (10) 74.2  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
Female
47
  39.2%
32
  26.7%
79
  32.9%
Male
73
  60.8%
88
  73.3%
161
  67.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 240 participants
New Zealand 12 14 26
United Kingdom 44 42 86
Australia 64 64 128
1.Primary Outcome
Title Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed 88 88
Mean (Standard Deviation)
Unit of Measure: percentage
-2.29  (10.5) -3.43  (8.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4347
Comments [Not Specified]
Method two-sided z-test
Comments [Not Specified]
2.Primary Outcome
Title Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed 89 59
Mean (Standard Deviation)
Unit of Measure: percentage
-2.04  (10.4) -3.60  (7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments [Not Specified]
Method two-sided z-test
Comments [Not Specified]
3.Secondary Outcome
Title Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed 90 96
Mean (Standard Deviation)
Unit of Measure: minutes per day
56.47  (22.61) 24.11  (14.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2257
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed 98 60
Mean (Standard Deviation)
Unit of Measure: minutes per day
40.98  (20.04) 6.66  (4.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5480
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Hide Description [Not Specified]
Time Frame At 5-years follow-up (study extension)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed 50 58
Mean (Standard Deviation)
Unit of Measure: minutes per day
17.73  (11.95) 63.83  (36.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8868
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Hide Description [Not Specified]
Time Frame At 5-year follow-up (study extension)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed 59 32
Mean (Standard Deviation)
Unit of Measure: minutes per day
62.75  (36.21) 18.61  (16.61)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6151
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Worsening of Heart Failure
Hide Description

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.
Time Frame At 5-year follow-up (study extension)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site
RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed 78 81
Measure Type: Number
Unit of Measure: episodes
19 17
8.Secondary Outcome
Title All Cause Mortality
Hide Description [Not Specified]
Time Frame At 5-year follow-up (study extension)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site
RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed 78 81
Measure Type: Number
Unit of Measure: participants
14 11
9.Secondary Outcome
Title Incidence of Stroke
Hide Description [Not Specified]
Time Frame At 5-year follow-up (study extension)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site
RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed 78 81
Measure Type: Number
Unit of Measure: participants
5 6
10.Secondary Outcome
Title Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
Overall Number of Participants Analyzed 72 71
Median (Full Range)
Unit of Measure: picograms per milliliter
138.2
(0.3 to 1428)
111.3
(0.3 to 1536)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0525
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed 72 48
Median (Full Range)
Unit of Measure: picograms per milliliter
176.6
(0.3 to 1428)
110.8
(0.3 to 1429)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1852
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Echocardiographic Measures of Left Ventricular Dyssynchrony
Hide Description No analysis has been done for this section since that variable was not collected during the study.
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis has been done for this section since that variable was not collected during the study
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site
RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title 6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)
RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed 67 68
Median (Inter-Quartile Range)
Unit of Measure: meters
391
(307 to 475)
395
(320 to 463.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9719
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title 6 Minute Hall-Walk Distance (Per Protocol Cohort)
Hide Description [Not Specified]
Time Frame At 2-year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Cohort with data available
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description:
RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)
RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed 68 47
Median (Inter-Quartile Range)
Unit of Measure: meters
385.5
(304.5 to 477.5)
426.5
(355.5 to 480)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RV Apex, RV High Septum
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8779
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RV Apex RV High Septum
Hide Arm/Group Description RV lead placement site: Patients randomised to RV apical lead placement site RV lead placement site: Patients randomised to RV high septal lead placement site
All-Cause Mortality
RV Apex RV High Septum
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
RV Apex RV High Septum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/120 (65.00%)      81/120 (67.50%)    
Blood and lymphatic system disorders     
anemia * 1  3/120 (2.50%)  3 3/120 (2.50%)  3
Cardiac disorders     
SOB * 1  25/120 (20.83%)  34 29/120 (24.17%)  50
product issue * 1 [1]  9/120 (7.50%)  9 11/120 (9.17%)  15
Endocrine disorders     
diabets * 1  1/120 (0.83%)  1 2/120 (1.67%)  3
Gastrointestinal disorders     
rectal bleeding * 1  11/120 (9.17%)  12 7/120 (5.83%)  7
General disorders     
chest pain * 1  10/120 (8.33%)  13 9/120 (7.50%)  9
death * 1  19/120 (15.83%)  19 16/120 (13.33%)  16
Hepatobiliary disorders     
bile duct * 1  2/120 (1.67%)  3 2/120 (1.67%)  2
Infections and infestations     
infection * 1  3/120 (2.50%)  3 1/120 (0.83%)  1
Injury, poisoning and procedural complications     
trauma * 1  10/120 (8.33%)  10 20/120 (16.67%)  23
Investigations     
angiography * 1  2/120 (1.67%)  2 1/120 (0.83%)  1
Metabolism and nutrition disorders     
dehydration * 1  0/120 (0.00%)  0 1/120 (0.83%)  2
Musculoskeletal and connective tissue disorders     
arthritis * 1  6/120 (5.00%)  9 6/120 (5.00%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
carcinoma * 1  8/120 (6.67%)  10 8/120 (6.67%)  15
Nervous system disorders     
stroke * 1  4/120 (3.33%)  8 9/120 (7.50%)  12
Renal and urinary disorders     
urinary tract infection * 1  5/120 (4.17%)  5 3/120 (2.50%)  3
Reproductive system and breast disorders     
prostate * 1  1/120 (0.83%)  1 2/120 (1.67%)  2
Respiratory, thoracic and mediastinal disorders     
pneumonia * 1  9/120 (7.50%)  11 8/120 (6.67%)  10
Skin and subcutaneous tissue disorders     
dermatitis * 1  2/120 (1.67%)  2 1/120 (0.83%)  1
Surgical and medical procedures     
bypass * 1  7/120 (5.83%)  10 5/120 (4.17%)  5
Vascular disorders     
raynaud's disease * 1  11/120 (9.17%)  12 8/120 (6.67%)  13
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
[1]
Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RV Apex RV High Septum
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/120 (5.00%)      0/120 (0.00%)    
Musculoskeletal and connective tissue disorders     
musculoskeletal pain * 1  6/120 (5.00%)  6 0/120 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gerald Kaye
Organization: Princess Alexandra Hospital
Phone: 07 3176 2111
EMail: gerald.kaye@health.qld.gov.au
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00461734    
Other Study ID Numbers: PROTECT-PACE Version 4
First Submitted: April 17, 2007
First Posted: April 18, 2007
Results First Submitted: September 15, 2016
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017