Trial Outcomes & Findings for Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure (NCT NCT02367716)
NCT ID: NCT02367716
Last Updated: 2020-11-18
Results Overview
The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants.
Recruitment status
COMPLETED
Target enrollment
121 participants
Primary outcome timeframe
From implantation to 6 months after implant procedure.
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Treatment Arm- St. Jude Medical Quartet™ LV Lead Model 1458Q
This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial St. Jude Medical (SJM) Quartet™ Left Ventricular (LV) lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
This is a single arm study.
The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016.
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|---|---|
|
Overall Study
STARTED
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121
|
|
Overall Study
COMPLETED
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120
|
|
Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Treatment Arm- St. Jude Medical Quartet™ LV Lead Model 1458Q
This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial St. Jude Medical (SJM) Quartet™ Left Ventricular (LV) lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
This is a single arm study.
The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016.
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|---|---|
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Overall Study
Patient did not meet inclusion criteria
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1
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Baseline Characteristics
A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=120 Participants
This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
This is a single arm study.
The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016.
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|---|---|
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Age, Continuous
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59.9 years
STANDARD_DEVIATION 11.0 • n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator.
|
|
Sex: Female, Male
Female
|
39 Participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator.
|
|
Sex: Female, Male
Male
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81 Participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator.
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|
New York Heart Association (NYHA) Class, n (%)
Class I
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1 Participants
n=120 Participants • NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
|
|
New York Heart Association (NYHA) Class, n (%)
Class II
|
38 Participants
n=120 Participants • NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
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|
New York Heart Association (NYHA) Class, n (%)
Class III
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63 Participants
n=120 Participants • NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
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|
New York Heart Association (NYHA) Class, n (%)
Class IV
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15 Participants
n=120 Participants • NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
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|
New York Heart Association (NYHA) Class, n (%)
Not Done
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3 Participants
n=120 Participants • NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
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Intrinsic QRS Duration
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158 milliseconds (ms)
STANDARD_DEVIATION 27.6 • n=113 Participants • A total of 113 patients had intrinsic QRS duration measured at baseline and are included in the analysis population.
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Primary Cause of Cardiac Disease, n (%)
Ischemic
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12 Participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Primary Cause of Cardiac Disease, n (%)
Non-Ischemic
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108 Participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
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Prior Cardiac Interventions, n (%)
Coronary Artery Bypass Graft
|
0 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Prior Cardiac Interventions, n (%)
PTCA/Stents/Atherectomy
|
9 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
ACE Inhibitors
|
73 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
Adrenergics
|
1 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
Aldosterone Antagonist
|
29 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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|
Cardiac Medications, n (%)
Angiotensin Receptor Blocker
|
29 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
Anti-Arrhythmics
|
31 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
Anticoagulants
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8 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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|
Cardiac Medications, n (%)
Antiplatelets
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37 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
Beta Blockers
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87 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
Calcium Channel Blockers
|
5 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
Cardiac Glycosides
|
52 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
Diuretics
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100 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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Cardiac Medications, n (%)
Nitrates
|
20 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
Statins
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22 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
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|
Cardiac Medications, n (%)
Other
|
51 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
|
Cardiac Medications, n (%)
None
|
6 participants
n=120 Participants • A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator
|
PRIMARY outcome
Timeframe: From implantation to 6 months after implant procedure.Population: Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis.
The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants.
Outcome measures
| Measure |
Treatment Arm of SJM Quartet™ LV Lead Model 1458Q
n=120 Participants
Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
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|---|---|
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The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)
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2 Participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis.
The effectiveness endpoint is the number of participants with effective LV pacing compared to the total number of analyzed participants. The following must be met to be considered effective LV pacing: * Pacing threshold (immediately after implant): for pacing threshold at a pulse width of 0.5 ms, the voltage must be ≤3.5 Voltage (V) in any LV lead vector. * Pacing stability (pre-discharge, 3 months and 6 months after implant): for pacing threshold at a pulse width of 0.5 ms, the voltage must be ≤6.0V in any LV lead vector. * Pacing impedance (immediately after implant): Impedance value in any LV lead vector must be in the normal range of 200-2000 ohm (Ω). * Table 9: Impedance stability (pre-discharge, 3 months and 6 months after implant): Impedance value in any LV lead vector must be in the normal range of 200-2000Ω.
Outcome measures
| Measure |
Treatment Arm of SJM Quartet™ LV Lead Model 1458Q
n=64 Participants
Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
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|---|---|
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The Number of Participants With Effective LV Pacing
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48 Participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis.
This secondary objective is to count the number of participants in each NYHA functional class at 6 months; NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.
Outcome measures
| Measure |
Treatment Arm of SJM Quartet™ LV Lead Model 1458Q
n=105 Participants
Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
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|---|---|
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The Number of Participants in Each NYHA Functional Class
NYHA Class I
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12 Participants
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The Number of Participants in Each NYHA Functional Class
NYHA Class II
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61 Participants
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The Number of Participants in Each NYHA Functional Class
NYHA Class III
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26 Participants
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The Number of Participants in Each NYHA Functional Class
NYHA Class IV
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3 Participants
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The Number of Participants in Each NYHA Functional Class
NYHA Not Done
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3 Participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in the analysis.
This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.
Outcome measures
| Measure |
Treatment Arm of SJM Quartet™ LV Lead Model 1458Q
n=76 Participants
Enrolled in the treatment arm were patients implanted with the commercial SJM Quartet™ LV lead model 1458Q and any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
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|---|---|
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The Intrinsic QRS Duration of Participants
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141.9 Milliseconds
Standard Deviation 27.8
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Adverse Events
Treatment Arm
Serious events: 11 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment Arm
n=120 participants at risk
This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
This is a single arm study.
The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016.
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|---|---|
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Product Issues
Lead Dislodgement
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2.5%
3/120 • Number of events 3 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
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Product Issues
Hematoma/Seroma
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0.83%
1/120 • Number of events 1 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
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Product Issues
Inappropriate Shocks
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3.3%
4/120 • Number of events 5 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
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Infections and infestations
Infection
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2.5%
3/120 • Number of events 3 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
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|
Injury, poisoning and procedural complications
Pneumothorax/Hemothorax
|
0.83%
1/120 • Number of events 1 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
|
|
Product Issues
Rise in Threshold and Exit Block
|
0.83%
1/120 • Number of events 1 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
|
Other adverse events
| Measure |
Treatment Arm
n=120 participants at risk
This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P).
This is a single arm study.
The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016.
|
|---|---|
|
Infections and infestations
Infection
|
0.83%
1/120 • Number of events 1 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
|
|
Injury, poisoning and procedural complications
Pneumothorax/Hemothorax
|
0.83%
1/120 • Number of events 1 • Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor: * All Adverse Device Effects (ADEs), including procedure-related events * All Serious Adverse Devise Effects (SADEs) including procedure-related events * All deaths
|
Additional Information
Clay Cohorn, Clinical Program Director
Cardiac Rhythm Management, Abbott Medical Devices
Phone: +19723098087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place