Chronic Heart Failure
Conditions
Brief summary
The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).
Detailed description
This is a multi-center, non-randomized observational study. The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.
Interventions
DEVICECRT
The study will include the Quartet™ family of left heart leads or any newer St. Jude Medical quadripolar CRT systems, including CRT-P systems, that China Food and Drug Administration (CFDA) might approve in the future
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets the current European Society of Cardiology (ESC) or American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS) Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber Implantable Cardioverter-Defibrillators (ICDs)) * Are ≥ 18 years of age at the time of enrolment. * Are able to provide written Informed Consent prior to any study related procedure.
Exclusion criteria
* Patient who is unable to comply with the follow-up schedule. * Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study . * Patient has a life expectancy of less than 1 year due to any condition. * Patients, who has a CRT device implanted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) | From implantation to 6 months after implant procedure. | The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Intrinsic QRS Duration of Participants | 6 months | This secondary objective is to measure the intrinsic QRS duration of participants at 6 months. |
| The Number of Participants With Effective LV Pacing | 6 months | 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. |
| The Number of Participants in Each NYHA Functional Class | 6 months | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm 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. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient did not meet inclusion criteria | 1 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 11 |
| Cardiac Medications, n (%) ACE Inhibitors | 73 participants |
| Cardiac Medications, n (%) Adrenergics | 1 participants |
| Cardiac Medications, n (%) Aldosterone Antagonist | 29 participants |
| Cardiac Medications, n (%) Angiotensin Receptor Blocker | 29 participants |
| Cardiac Medications, n (%) Anti-Arrhythmics | 31 participants |
| Cardiac Medications, n (%) Anticoagulants | 8 participants |
| Cardiac Medications, n (%) Antiplatelets | 37 participants |
| Cardiac Medications, n (%) Beta Blockers | 87 participants |
| Cardiac Medications, n (%) Calcium Channel Blockers | 5 participants |
| Cardiac Medications, n (%) Cardiac Glycosides | 52 participants |
| Cardiac Medications, n (%) Diuretics | 100 participants |
| Cardiac Medications, n (%) Nitrates | 20 participants |
| Cardiac Medications, n (%) None | 6 participants |
| Cardiac Medications, n (%) Other | 51 participants |
| Cardiac Medications, n (%) Statins | 22 participants |
| Intrinsic QRS Duration | 158 milliseconds (ms) STANDARD_DEVIATION 27.6 |
| New York Heart Association (NYHA) Class, n (%) Class I | 1 Participants |
| New York Heart Association (NYHA) Class, n (%) Class II | 38 Participants |
| New York Heart Association (NYHA) Class, n (%) Class III | 63 Participants |
| New York Heart Association (NYHA) Class, n (%) Class IV | 15 Participants |
| New York Heart Association (NYHA) Class, n (%) Not Done | 3 Participants |
| Primary Cause of Cardiac Disease, n (%) Ischemic | 12 Participants |
| Primary Cause of Cardiac Disease, n (%) Non-Ischemic | 108 Participants |
| Prior Cardiac Interventions, n (%) Coronary Artery Bypass Graft | 0 participants |
| Prior Cardiac Interventions, n (%) PTCA/Stents/Atherectomy | 9 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 120 |
| other Total, other adverse events | 2 / 120 |
| serious Total, serious adverse events | 11 / 120 |
Outcome results
Primary
The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)
The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) | 2 Participants |
Secondary
The Intrinsic QRS Duration of Participants
This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.
Time frame: 6 months
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 the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Intrinsic QRS Duration of Participants | 141.9 Milliseconds | Standard Deviation 27.8 |
Secondary
The Number of Participants in Each NYHA Functional Class
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.
Time frame: 6 months
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants in Each NYHA Functional Class | NYHA Class I | 12 Participants |
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants in Each NYHA Functional Class | NYHA Class II | 61 Participants |
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants in Each NYHA Functional Class | NYHA Class III | 26 Participants |
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants in Each NYHA Functional Class | NYHA Class IV | 3 Participants |
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants in Each NYHA Functional Class | NYHA Not Done | 3 Participants |
Secondary
The Number of Participants With Effective LV Pacing
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.
Time frame: 6 months
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm of SJM Quartet™ LV Lead Model 1458Q | The Number of Participants With Effective LV Pacing | 48 Participants |