Post-market Study of Multi-Vector LV Lead Performance in Chinese Patients With Chronic Heart Failure
This trial is active, not recruiting.
|Condition||chronic heart failure|
|Sponsor||St. Jude Medical|
|Start date||December 2014|
|End date||February 2017|
|Trial size||121 participants|
|Trial identifier||NCT02367716, SJM- CIP-CRD 733|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Hefei, China||Anhui Provincial Hospital||no longer recruiting|
|Hefei, China||The second Affliated hospital Anhui Medical University||no longer recruiting|
|Guangzhou, China||The second Affiliated hospital of Sun Yat-Sen University||no longer recruiting|
|Shijiazhuang, China||The second hospital of Hebei Medical University||no longer recruiting|
|Nanjing, China||Nanjing Drum Tower Hospital||no longer recruiting|
|Nanjing, China||Jiangsu Province Hospital||no longer recruiting|
|Nanjing, China||Nanjing First Hospital Affiliated to Nanjing Medical University||no longer recruiting|
|Hangzhou, China||Zhejiang Greentown cardiovascular hospital||no longer recruiting|
|Hangzhou, China||The First Affiliated hospital of Medical College of Zhejiang University||no longer recruiting|
|Hangzhou, China||The second Affiliated hospital Zhejiang University School of Medicine||no longer recruiting|
|Hangzhou, China||Sir Runrun Shaw Hospital College of Medicine Zhejiang University||no longer recruiting|
|Beijing, China||Fuwai Hospital CAMS&PUMC||no longer recruiting|
|Shanghai, China||Rui Jin hospital Shanghai Jiao Tong University School of Medicine||no longer recruiting|
|Shanghai, China||Zhongshan Hospital Fudan University||no longer recruiting|
The occurrence rate of LV leads related SADE
time frame: from implantation to 6 months after implant procedure.
Male or female participants at least 18 years old.
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
|Official title||Post-market Study of Multi-Vector LV Lead Performance in Chinese Patients With Chronic Heart Failure|
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