Trial Outcomes & Findings for Optimize RV Selective Site Pacing Clinical Trial (NCT NCT00422669)
NCT ID: NCT00422669
Last Updated: 2013-01-31
Results Overview
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2013-01-31
Participant Flow
Enrollments in the Optimize RV trial began in March of 2007. The study was terminated early on March 26, 2009 after 205 subjects had been enrolled.
Seven subjects did not meet inclusion/exclusion criteria.
Participant milestones
| Measure |
RV Mid-Septal Pacing
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
|
RV Apical Pacing
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
|
Not Randomized
7 of the 205 subjects did not meet inclusion/exclusion criteria.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
98
|
100
|
7
|
Reasons for withdrawal
| Measure |
RV Mid-Septal Pacing
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
|
RV Apical Pacing
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
|
Not Randomized
7 of the 205 subjects did not meet inclusion/exclusion criteria.
|
|---|---|---|---|
|
Overall Study
The study was terminated early.
|
98
|
100
|
7
|
Baseline Characteristics
Optimize RV Selective Site Pacing Clinical Trial
Baseline characteristics by cohort
| Measure |
RV Mid-Septal Pacing
n=98 Participants
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
|
RV Apical Pacing
n=100 Participants
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
|
Not Randomized
n=7 Participants
7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
77.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
77.1 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
77.1 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Gender
Female
|
37 participants
n=5 Participants
|
39 participants
n=7 Participants
|
NA participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Gender
Male
|
61 participants
n=5 Participants
|
61 participants
n=7 Participants
|
NA participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
78 participants
n=7 Participants
|
7 participants
n=5 Participants
|
160 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
0 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 monthsPopulation: Data required for the analysis were not collected due to early study termination. Analysis will not be done.
Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.
Outcome measures
Outcome data not reported
Adverse Events
Subjects With Implant
Serious events: 50 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects With Implant
n=198 participants at risk
All 198 subjects with implant were included in this group.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Aortic valve stenosis
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac failure
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
4/198 • Number of events 4 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac perforation
|
2.5%
5/198 • Number of events 5 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac tamponade
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac valve disease
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Coronary artery stenosis
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Device failure
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Investigations
Ejection fraction decreased
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Failure to capture
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Vascular disorders
Hypertension
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Gastrointestinal disorders
Ileus
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
General disorders
Implant site haematoma
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Intracardiac thrombus
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
1.5%
3/198 • Number of events 3 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Nervous system disorders
Loss of consciousness
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
4/198 • Number of events 4 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Infections and infestations
Pneumonia
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
3/198 • Number of events 3 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Renal and urinary disorders
Renal failure chronic
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Infections and infestations
Staphylococcal sepsis
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Ventricular fibrillation
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Ventricular tachycardia
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Infections and infestations
Viral infection
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
Other adverse events
| Measure |
Subjects With Implant
n=198 participants at risk
All 198 subjects with implant were included in this group.
|
|---|---|
|
Gastrointestinal disorders
Abdominal mass
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Angina pectoris
|
1.0%
2/198 • Number of events 2 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/198 • Number of events 3 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Cardiac flutter
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
General disorders
Chest discomfort
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Infections and infestations
Herpes zoster
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
General disorders
Non-cardiac chest pain
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Cardiac disorders
Pacemaker generated arrhythmia
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Nervous system disorders
Syncope
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
|
Infections and infestations
Urinary tract infection
|
0.51%
1/198 • Number of events 1 • All adverse events reported before the study termination were included.
Adverse Events were not separated by randomization assignment as there was no subject data analysis completed due to early study termination. All Adverse Events were reviewed by a Central Adverse Event Advisory Committee. All serious adverse events were reported. All non-serious adverse events were reported in the table "other adverse events".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.
- Publication restrictions are in place
Restriction type: OTHER