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).
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.
Study Type
OBSERVATIONAL
Enrollment
121
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
Anhui Provincial Hospital
Hefei, Anhui, China
The second Affliated hospital Anhui Medical University
Hefei, Anhui, China
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.
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
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
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
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The second Affiliated hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The second hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Zhejiang Greentown cardiovascular hospital
Hangzhou, Zhejiang, China
The First Affiliated hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
The second Affiliated hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
...and 4 more locations