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Post-market Study of Multi-Vector LV Lead Performance in Chinese Patients With Chronic Heart Failure

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Heart Failure

Intervention: CRT (Device)

Phase: N/A

Status: Recruiting

Sponsored by: St. Jude Medical

Overall contact:
Ye Wang, Phone: +86 186 0119 6239, Email: awang06@sjm.com

Summary

The purpose of this clinical study is to observe the safety and efficacy of the multi-vector 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, 12months and every 6 months afterwards. All subjects need to be followed for at least 6 months.

Clinical Details

Official title: Post-market Study of Multi-Vector LV Lead Performance in Chinese Patients With Chronic Heart Failure

Study design: Observational Model: Case-Only, Time Perspective: Cross-Sectional

Primary outcome: The occurrence rate of LV leads related SADE

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- • Meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT

implant (including upgrades from single or dual chamber 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

Locations and Contacts

Ye Wang, Phone: +86 186 0119 6239, Email: awang06@sjm.com

Fuwai Hospital CAMS&PUMC, Beijing 100037, China; Not yet recruiting
Wei Hua

Rui Jin hospital Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China; Not yet recruiting
Liqun Wu

Zhongshan Hospital Fudan University, Shanghai 200032, China; Not yet recruiting
Yangang Su

Anhui Provincial Hospital, Hefei, Anhui 230001, China; Not yet recruiting
Ji Yan

The second Affliated hospital Anhui Medical University, Hefei, Anhui 230601, China; Not yet recruiting
Banglong Xu, Email: xubanglong@126.com

The second Affiliated hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510235, China; Not yet recruiting
Jingfeng Wang

The second hospital of Hebei Medical University, Shijiazhuang, Hebei 050000, China; Not yet recruiting
Fan Liu, Email: pub@hb2h.com

Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China; Not yet recruiting
Kejiang Cao

Nanjing Drum Tower Hospital, Nanjing, Jiangsu 210008, China; Not yet recruiting
Wei Xu

Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu 210029, China; Not yet recruiting
Zuoying Hu, Phone: +86 25 52271000

Sir Runrun Shaw Hospital College of Medicine Zhejiang University, Hangzhou, Zhejiang 310016, China; Not yet recruiting
Guosheng Fu

The First Affiliated hospital of Medical College of Zhejiang University, Hangzhou, Zhejiang 310003, China; Not yet recruiting
Liangrong Zheng

The second Affiliated hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China; Not yet recruiting
Geng Xu

Zhejiang Greentown cardiovascular hospital, Hangzhou, Zhejiang 310000, China; Recruiting
Farong Shen

Additional Information

Starting date: December 2014
Last updated: February 12, 2015

Page last updated: August 23, 2015

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