Trial Outcomes & Findings for Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead (NCT NCT01856491)
NCT ID: NCT01856491
Last Updated: 2019-04-30
Results Overview
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
167 participants
Primary outcome timeframe
3-months
Results posted on
2019-04-30
Participant Flow
Participant milestones
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
|
|---|---|
|
Overall Study
STARTED
|
167
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
Baseline characteristics by cohort
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=167 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
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Age, Continuous
|
66.90 years
STANDARD_DEVIATION 10.47 • n=93 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: 3-monthsPopulation: 167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=165 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
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Complication Free Rate
|
97.5 percentage of patients without event
Interval 94.4 to 100.0
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SECONDARY outcome
Timeframe: 3 months through 15 months post implantPopulation: Subjects were eligible for the secondary endpoint analysis if their date of last follow-up was ≥92 days post-implant procedure.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=158 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
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Complication Free Rate
|
99.4 percentage of patients without events
Interval 95.0 to 100.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months Post-ImplantPopulation: 167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected .
Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=138 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
|
Pacing Threshold at 0.5 ms Pulse Width
|
0.48 Volt
Standard Deviation 0.59
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 months through 24 months post implantLead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=158 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
|
|---|---|
|
Complication Free Rate
|
99.4 percentage of patients without events
Interval 95.0 to 100.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months Post-ImplantPopulation: 167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months
Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=141 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
|
Sensed Amplitude
|
18.5 mVolt
Standard Deviation 5.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 Months Post-ImplantPopulation: 167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance
Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Outcome measures
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=150 Participants
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
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Pacing Impedance
|
474 Ohm
Standard Deviation 106
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Adverse Events
RELIANCE 4-FRONT™ Passive Fixation
Serious events: 84 serious events
Other events: 55 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=167 participants at risk
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
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|---|---|
|
Cardiac disorders
Inappropriate tachy therapy - SVT
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
Erosion
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Infections and infestations
Infection (> 30 days post-implant)
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
Psychiatric disorders
Psychological effect due to device therapy
|
0.60%
1/167 • Number of events 2 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
Post-surgical wound discomfort
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Infections and infestations
Post-surgical infection (<= 30 days post-implant)
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
Hematoma - Pocket (<=30 days post-implant)
|
2.4%
4/167 • Number of events 4 • 3-month follow-up data
|
|
General disorders
Conductor coil fracture - RA
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
General disorders
Elevated threshold - RV
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
General disorders
Dislodgment - Unable to capture - LV
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Injury, poisoning and procedural complications
Pneumothorax - Procedure
|
1.2%
2/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Ventricular fibrillation (VF)
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
1.8%
3/167 • Number of events 6 • 3-month follow-up data
|
|
Cardiac disorders
Atrial flutter
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Other SVT (AVRT, AVNRT, EAT etc.)
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Heart failure
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Dyspnea - Heart failure
|
4.8%
8/167 • Number of events 11 • 3-month follow-up data
|
|
Cardiac disorders
Peripheral edema - Heart failure
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Pulmonary edema - Heart failure
|
2.4%
4/167 • Number of events 6 • 3-month follow-up data
|
|
Cardiac disorders
Heart failure symptoms - Unspecified
|
3.6%
6/167 • Number of events 8 • 3-month follow-up data
|
|
Cardiac disorders
Multiple heart failure symptoms
|
2.4%
4/167 • Number of events 5 • 3-month follow-up data
|
|
Cardiac disorders
Multi-system failure - Heart failure
|
3.0%
5/167 • Number of events 5 • 3-month follow-up data
|
|
Vascular disorders
Hypotension
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Vascular disorders
Hypertension
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
RELATED TO ISCHEMIA
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Myocardial infarction
|
3.6%
6/167 • Number of events 6 • 3-month follow-up data
|
|
Vascular disorders
Coronary Artery Disease
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Vascular disorders
Coronary artery disease
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Vascular disorders
Peripheral vascular disease
|
1.8%
3/167 • Number of events 4 • 3-month follow-up data
|
|
Vascular disorders
Intermittent claudication
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Mitral regurgitation
|
0.60%
1/167 • Number of events 2 • 3-month follow-up data
|
|
Cardiac disorders
Syncope
|
1.8%
3/167 • Number of events 4 • 3-month follow-up data
|
|
Cardiac disorders
Dizziness
|
1.2%
2/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Ischemic
|
0.60%
1/167 • Number of events 2 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Other
|
3.6%
6/167 • Number of events 7 • 3-month follow-up data
|
|
General disorders
Fatigue
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
3.6%
6/167 • Number of events 6 • 3-month follow-up data
|
|
Vascular disorders
Pulmonary embolism (PE)
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Vascular disorders
Intracardiac thrombus
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
General disorders
Hematoma - Unrelated to procedure or device
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
General disorders
Death
|
2.4%
4/167 • Number of events 4 • 3-month follow-up data
|
|
Infections and infestations
Systemic infection
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
General disorders
Fever
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Injury, poisoning and procedural complications
Physical trauma
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Blood and lymphatic system disorders
Abnormal laboratory values
|
1.8%
3/167 • Number of events 4 • 3-month follow-up data
|
|
Blood and lymphatic system disorders
Hematological
|
3.0%
5/167 • Number of events 7 • 3-month follow-up data
|
|
Nervous system disorders
Neurological
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Gastrointestinal disorders
Gastrointestinal
|
6.0%
10/167 • Number of events 11 • 3-month follow-up data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
5.4%
9/167 • Number of events 13 • 3-month follow-up data
|
|
Renal and urinary disorders
Genitourinary
|
4.2%
7/167 • Number of events 14 • 3-month follow-up data
|
|
Renal and urinary disorders
Renal
|
4.2%
7/167 • Number of events 9 • 3-month follow-up data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.60%
1/167 • Number of events 2 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Endocrine disorders
Endocrine
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
General disorders
Multi-system failure
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
Other adverse events
| Measure |
RELIANCE 4-FRONT™ Passive Fixation
n=167 participants at risk
Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead
RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
|
|---|---|
|
General disorders
Not yet classified
|
1.8%
3/167 • Number of events 4 • 3-month follow-up data
|
|
Cardiac disorders
Inappropriate tachy therapy - SVT
|
2.4%
4/167 • Number of events 5 • 3-month follow-up data
|
|
Cardiac disorders
Inappropriate tachy therapy - Other
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Surgical and medical procedures
Post-surgical wound discomfort
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Inadvertent VT/VF
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Cardiac disorders
Elevated threshold - RA
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Elevated threshold - RV
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Vascular disorders
Coronary venous dissection
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Ventricular fibrillation (VF)
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Cardiac disorders
Ventricular tachycardia (VT)
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Atrial fibrillation (AF)
|
2.4%
4/167 • Number of events 5 • 3-month follow-up data
|
|
Cardiac disorders
Other SVT (AVRT, AVNRT, EAT etc.)
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
Cardiac disorders
Syncope - Heart failure
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Heart failure
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Dyspnea - Heart failure
|
4.2%
7/167 • Number of events 8 • 3-month follow-up data
|
|
Cardiac disorders
Multiple heart failure symptoms
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Hypertension - Heart failure
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Ischemic
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Cardiac disorders
Chest pain - Other
|
4.2%
7/167 • Number of events 7 • 3-month follow-up data
|
|
Cardiac disorders
Palpitations
|
1.8%
3/167 • Number of events 3 • 3-month follow-up data
|
|
General disorders
Fatigue
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Surgical and medical procedures
Hemorrhage
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
General disorders
Physical trauma
|
3.6%
6/167 • Number of events 6 • 3-month follow-up data
|
|
Blood and lymphatic system disorders
Hematological
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.0%
5/167 • Number of events 10 • 3-month follow-up data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
Renal and urinary disorders
Genitourinary
|
2.4%
4/167 • Number of events 5 • 3-month follow-up data
|
|
Renal and urinary disorders
Renal
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
3.6%
6/167 • Number of events 12 • 3-month follow-up data
|
|
Psychiatric disorders
Psychological
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
Integumentary
|
1.8%
3/167 • Number of events 5 • 3-month follow-up data
|
|
General disorders
Head, eyes, ears, nose, throat (HEENT)
|
6.0%
10/167 • Number of events 12 • 3-month follow-up data
|
|
Endocrine disorders
Endocrine
|
1.2%
2/167 • Number of events 2 • 3-month follow-up data
|
|
General disorders
Cancer
|
1.2%
2/167 • Number of events 4 • 3-month follow-up data
|
|
General disorders
medication side effect
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
|
Skin and subcutaneous tissue disorders
pain in device pocket
|
0.60%
1/167 • Number of events 1 • 3-month follow-up data
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60