Trial Outcomes & Findings for MediGuide Registry (NCT NCT02470312)
NCT ID: NCT02470312
Last Updated: 2019-02-04
Results Overview
Amount of fluoroscopy time during CRT implant or EP procedure
Recruitment status
TERMINATED
Target enrollment
578 participants
Primary outcome timeframe
Expected time frame is day 1 of the study
Results posted on
2019-02-04
Participant Flow
Participant milestones
| Measure |
CRT Group
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
431
|
|
Overall Study
COMPLETED
|
142
|
419
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CRT Group
n=147 Participants
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
n=431 Participants
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 10.3 • n=147 Participants
|
62.5 years
STANDARD_DEVIATION 12.5 • n=431 Participants
|
64.6 years
STANDARD_DEVIATION 12.5 • n=578 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=147 Participants
|
129 Participants
n=431 Participants
|
171 Participants
n=578 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=147 Participants
|
302 Participants
n=431 Participants
|
407 Participants
n=578 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
36 participants
n=147 Participants
|
28 participants
n=431 Participants
|
64 participants
n=578 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=147 Participants
|
11 participants
n=431 Participants
|
11 participants
n=578 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=147 Participants
|
16 participants
n=431 Participants
|
16 participants
n=578 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=147 Participants
|
90 participants
n=431 Participants
|
162 participants
n=578 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=147 Participants
|
26 participants
n=431 Participants
|
26 participants
n=578 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=147 Participants
|
132 participants
n=431 Participants
|
139 participants
n=578 Participants
|
|
Region of Enrollment
Estonia
|
25 participants
n=147 Participants
|
27 participants
n=431 Participants
|
52 participants
n=578 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=147 Participants
|
46 participants
n=431 Participants
|
46 participants
n=578 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=147 Participants
|
3 participants
n=431 Participants
|
5 participants
n=578 Participants
|
|
Region of Enrollment
Taiwan
|
0 participants
n=147 Participants
|
10 participants
n=431 Participants
|
10 participants
n=578 Participants
|
|
NYHA classification
NYHA I
|
2 Participants
n=147 Participants
|
120 Participants
n=431 Participants
|
122 Participants
n=578 Participants
|
|
NYHA classification
NYHA II
|
45 Participants
n=147 Participants
|
102 Participants
n=431 Participants
|
147 Participants
n=578 Participants
|
|
NYHA classification
NYHA III
|
66 Participants
n=147 Participants
|
27 Participants
n=431 Participants
|
93 Participants
n=578 Participants
|
|
NYHA classification
NYHA IV
|
2 Participants
n=147 Participants
|
4 Participants
n=431 Participants
|
6 Participants
n=578 Participants
|
|
NYHA classification
NOT AVAILABLE
|
32 Participants
n=147 Participants
|
178 Participants
n=431 Participants
|
210 Participants
n=578 Participants
|
|
LEFT VENTRICULAR EJECTION FRACTION
|
29.1 PERCENTAGE
STANDARD_DEVIATION 10.2 • n=147 Participants
|
55.1 PERCENTAGE
STANDARD_DEVIATION 11.5 • n=431 Participants
|
48.0 PERCENTAGE
STANDARD_DEVIATION 16.1 • n=578 Participants
|
PRIMARY outcome
Timeframe: Expected time frame is day 1 of the studyAmount of fluoroscopy time during CRT implant or EP procedure
Outcome measures
| Measure |
CRT Group
n=142 Participants
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
n=419 Participants
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
|---|---|---|
|
Amount of Fluoroscopy Time
|
9.5 MINUTES
Standard Deviation 8.0
|
6.0 MINUTES
Standard Deviation 9.9
|
PRIMARY outcome
Timeframe: From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 daysAdverse event until patients are discharged from the site center
Outcome measures
| Measure |
CRT Group
n=142 Participants
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
n=419 Participants
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
|---|---|---|
|
Periprocedural Adverse Event
|
6 ADVERSE EVENTS
|
12 ADVERSE EVENTS
|
Adverse Events
CRT Group
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
EP Group
Serious events: 12 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRT Group
n=142 participants at risk
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
n=11 participants at risk；n=419 participants at risk
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
|---|---|---|
|
Cardiac disorders
Arrhyrhmia
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.48%
2/419 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Vascular disorders
Bleeding (non-hematoma)
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.00%
0/419 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
Cardiac Perforation
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.00%
0/419 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.24%
1/419 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
Coronary Sinus Perforation
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.00%
0/419 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.48%
2/419 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Nervous system disorders
Phrenic Nerve/Diaphragmatic Stimulation
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.00%
0/419 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Blood and lymphatic system disorders
Pseudoaneurysm
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.72%
3/419 • Number of events 3 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Vascular disorders
Stroke
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.48%
2/419 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
General disorders
Syncope Unknown Etiology
|
0.70%
1/142 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.00%
0/419 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
General disorders
OTHER
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
0.48%
2/419 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
Other adverse events
| Measure |
CRT Group
n=142 participants at risk
All subjects willing to provide written informed consent from participating sites, who were indicated for a CRT-D/P device implant (including an upgrade with a new LV lead) and were implanted with a SJM pulse generator, utilizing the MediGuide system and tools, were enrolled in this registry. Subjects could be implanted with non-SJM leads.
|
EP Group
n=11 participants at risk；n=419 participants at risk
All subjects willing to provide written informed consent from participating sites, who were undergoing ablation procedures for atrial fibrillation, atrial flutter and ventricular tachycardia, utilizing the MediGuide system and tools, were enrolled in this registry.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
9.1%
1/11 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Vascular disorders
Bleeding(Non-Hematoma)
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
18.2%
2/11 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
Chest Pain/Discomfort
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
18.2%
2/11 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
18.2%
2/11 • Number of events 2 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Cardiac disorders
New Or Worsened Angina
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
9.1%
1/11 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Infections and infestations
Pericarditis
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
9.1%
1/11 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Blood and lymphatic system disorders
Pseudoaneurysm
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
9.1%
1/11 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
|
Vascular disorders
Thromboembolism
|
0.00%
0/142 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
9.1%
1/11 • Number of events 1 • The safety surveillance and the safety reporting, both performed by the investigator, started as soon as the subject was enrolled in this study and continued until the last study visit has been completed, i.e. discharge visit, the subject is deceased, or the subject/investigator prematurely withdraws the subject from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place