Clinical trial NCT02367716: Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
Official title: Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)
timeFrame: From implantation to 6 months after implant procedure.
Secondary outcomes:
measure: The Number of Participants With Effective LV Pacing
timeFrame: 6 months
measure: The Number of Participants in Each NYHA Functional Class
timeFrame: 6 months
measure: The Intrinsic QRS Duration of Participants
timeFrame: 6 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The second Affliated hospital Anhui Medical University
state: Anhui
city: Guangzhou
country: China
facility: The second Affiliated hospital of Sun Yat-Sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The second hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Hangzhou
country: China
facility: Zhejiang Greentown cardiovascular hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated hospital of Medical College of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The second Affiliated hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Runrun Shaw Hospital College of Medicine Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Fuwai Hospital CAMS&PUMC
city: Shanghai
country: China
facility: Rui Jin hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Abbott
name: Clay Cohorn
role: STUDY_DIRECTOR
References: