Trial Outcomes & Findings for LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study (NCT NCT04732728)
NCT ID: NCT04732728
Last Updated: 2024-11-25
Results Overview
Recruitment status
COMPLETED
Target enrollment
727 participants
Primary outcome timeframe
30 days
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
LUX-Dx PERFORM Study Enrollment
The first 227 subjects enrolled in the study belonged to the "Safety Cohort". The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects were not required to participate in the Holter study. Once the "Safety Cohort" enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the "Holter Cohort".
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|---|---|
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Overall Study
STARTED
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727
|
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Overall Study
COMPLETED
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579
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Overall Study
NOT COMPLETED
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148
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Reasons for withdrawal
| Measure |
LUX-Dx PERFORM Study Enrollment
The first 227 subjects enrolled in the study belonged to the "Safety Cohort". The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects were not required to participate in the Holter study. Once the "Safety Cohort" enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the "Holter Cohort".
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|---|---|
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Overall Study
Death
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12
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Overall Study
Withdrawn
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136
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Baseline Characteristics
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
Baseline characteristics by cohort
| Measure |
LUX-Dx PERFORM Study Enrollment
n=727 Participants
The first 227 subjects enrolled in the study belonged to the "Safety Cohort". The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects were not required to participate in the Holter study. Once the "Safety Cohort" enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the "Holter Cohort".
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|---|---|
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Age, Continuous
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65.7 years
STANDARD_DEVIATION 13.9 • n=5 Participants
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Sex: Female, Male
Female
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372 Participants
n=5 Participants
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Sex: Female, Male
Male
|
355 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
|
634 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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60 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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5 Participants
n=5 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race - Other
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2 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Not disclosed
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27 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity Hispanic or Latino - Mexican
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15 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity Hispanic or Latino - Puerto Rican
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity Hispanic or Latino - Other
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30 daysPopulation: The acute primary safety endpoint was the LUX-Dx ICM system-related CFR at 30 days post-implant where the ICM system refers to the LUX-Dx ICM device, mobile applications, and the associated accessories used with the device. All implants and attempts with a de novo ICM are included in the at-risk group.
Outcome measures
| Measure |
LUX-Dx PERFORM Study Enrollment
n=687 Participants
The first 227 subjects enrolled in the study belong to the "Safety Cohort". The number of subjects is required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects are not required to participate in the Holter study. Once the "Safety Cohort" enrollment is completed, all subsequent subjects are required to participate in the Holter study. All subjects who participate in the Holter study belong to the "Holter Cohort".
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|---|---|
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ICM System-related Complication-free Rate at 30 Days Post-implant
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99.9 Percentage of participants
Interval 99.0 to
As prespecified in the study protocol the lower one-sided 97.5% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
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PRIMARY outcome
Timeframe: 12 monthsPopulation: The chronic primary safety endpoint was the LUX-Dx ICM system-related CFR at 12 months post-implant where the ICM system refers to the LUX-Dx ICM device, mobile applications, and the associated accessories used with the device. All implants and attempts with a de novo ICM are included in the at-risk group.
Outcome measures
| Measure |
LUX-Dx PERFORM Study Enrollment
n=687 Participants
The first 227 subjects enrolled in the study belong to the "Safety Cohort". The number of subjects is required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects are not required to participate in the Holter study. Once the "Safety Cohort" enrollment is completed, all subsequent subjects are required to participate in the Holter study. All subjects who participate in the Holter study belong to the "Holter Cohort".
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|---|---|
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ICM System-related Complication-free Rate at 12 Months Post-implant
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99.6 Percentage of participants
Interval 98.6 to
As prespecified in the study protocol the lower one-sided 97.5% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).
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Adverse Events
LUX-Dx PERFORM Study Enrollment
Serious events: 127 serious events
Other events: 152 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
LUX-Dx PERFORM Study Enrollment
n=727 participants at risk
The first 227 subjects enrolled in the study belonged to the "Safety Cohort". The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects were not required to participate in the Holter study. Once the "Safety Cohort" enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the "Holter Cohort".
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|---|---|
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Cardiac disorders
1st Degree AV Block
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
2nd Degree AV Block
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0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
3rd Degree AV Block
|
0.96%
7/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Abnormal Laboratory Values
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Atrial Fibrillation (AF)
|
2.5%
18/727 • Number of events 26 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Atrial Flutter
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0.41%
3/727 • Number of events 4 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
0.69%
5/727 • Number of events 5 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Cerebrovascular Accident (CVA)
|
1.2%
9/727 • Number of events 11 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Cerebrovascular accident (CVA) - ischemic
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Chest Pain - Ischemic
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0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Chest Pain - Other
|
0.69%
5/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Coronary Artery Disease
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Death
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0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
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Cardiac disorders
Dehydration - Heart Failure
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Dizziness
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0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Edema
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0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Endocrine disorders
Endocrine
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0.55%
4/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Fatigue/Weakness
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0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Infections and infestations
Fever and/or Virus
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0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Gastrointestinal disorders
Gastrointestinal
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1.7%
12/727 • Number of events 14 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Renal and urinary disorders
Genitourinary
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0.83%
6/727 • Number of events 6 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Blood and lymphatic system disorders
Hematological
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0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Vascular disorders
Hypertension/Hypertensive Crisis
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0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Infections and infestations
Localized Infection
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0.14%
1/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Multiple Heart Failure Symptoms
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1.2%
9/727 • Number of events 9 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Musculoskeletal and connective tissue disorders
Musculoskeletal
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0.96%
7/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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|
Vascular disorders
Myocardial Infarction
|
0.96%
7/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Nervous system disorders
Neurological
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1.1%
8/727 • Number of events 9 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Pericardial effusion - unrelated procedure/device
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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General disorders
Physical Trauma
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0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Cardiac disorders
Pleural Effusion - Heart Failure
|
0.14%
1/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
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Respiratory, thoracic and mediastinal disorders
Pneumothorax - unrelated procedure/device
|
0.14%
1/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
0.14%
1/718 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.96%
7/727 • Number of events 7 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Renal and urinary disorders
Renal
|
1.1%
8/727 • Number of events 8 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Sinus Bradycardia
|
1.2%
9/727 • Number of events 9 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Syncope
|
1.1%
8/727 • Number of events 9 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
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Infections and infestations
System Infection
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.55%
4/727 • Number of events 4 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Ventricular Fibrillation (VF)
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Product Issues
Dislodgement - Unable to capture - RV
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
Other adverse events
| Measure |
LUX-Dx PERFORM Study Enrollment
n=727 participants at risk
The first 227 subjects enrolled in the study belonged to the "Safety Cohort". The number of subjects was required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects were not required to participate in the Holter study. Once the "Safety Cohort" enrollment was completed, all subsequent subjects were required to participate in the Holter study. All subjects who participated in the Holter study belong to the "Holter Cohort".
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|---|---|
|
Vascular disorders
Hypertension/Hypertensive Crisis
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
2nd Degree AV Block
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
3rd Degree AV Block
|
0.69%
5/727 • Number of events 5 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Adverse Reaction - other
|
1.3%
9/718 • Number of events 9 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Atrial Fibrillation (AF)
|
6.6%
48/727 • Number of events 50 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Atrial Flutter
|
0.69%
5/727 • Number of events 5 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)
|
5.4%
39/727 • Number of events 72 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Chest Pain - Heart Failure
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Chest Pain - Other
|
0.55%
4/727 • Number of events 6 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Vascular disorders
Coronary Artery Disease
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Dyspnea - Heart Failure
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Product Issues
Erosion
|
0.14%
1/718 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Vascular disorders
Hypotension/Orthostatic Hypotension
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Infections and infestations
Infection (> 30 days post implant)
|
0.42%
3/718 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Multiple Heart Failure Symptoms
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Nervous system disorders
Neurological
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Nonsustained ventricular tachycardia (NSVT)
|
0.69%
5/727 • Number of events 5 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Product Issues
Other - ICM System
|
0.14%
1/718 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
PG System - Patient Related - OTHER
|
0.14%
1/718 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Patient Condition - Cardiovascular - OTHER
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Vascular disorders
Peripheral Vascular Disease
|
0.14%
1/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post Surgical wound discomfort/bruising/swelling
|
0.28%
2/718 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post -Surgical infection ( 30 days post implant)
|
0.56%
4/718 • Number of events 4 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Post-surgical pocket hemorrhage/bleeding/drainage
|
0.56%
4/718 • Number of events 4 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Premature Ventricular Contractions (PVC)
|
3.6%
26/727 • Number of events 28 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.14%
1/727 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Sinus Bradycardia
|
2.9%
21/727 • Number of events 21 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Syncope
|
1.4%
10/727 • Number of events 13 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Vascular disorders
Transient Ischemic Attack (TIA)
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Cardiac disorders
Ventricular Tachycardia (VT)/Monomorphic VT
|
0.41%
3/727 • Number of events 3 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
General disorders
Whole Body - OTHER
|
0.28%
2/727 • Number of events 2 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
|
Injury, poisoning and procedural complications
Device Expulsion
|
0.14%
1/718 • Number of events 1 • Adverse events were reported for all subjects following enrollment through their study end date. Subjects were considered to have completed the study after 12-Months of follow-up.
|
Additional Information
Thomas Stoltz, Clinical Trial Manager
Boston Scientific
Phone: 1-800-CARDIAC
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60