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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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CRT

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clay Cohorn

Role: STUDY_DIRECTOR

Abbott

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China

Other Identifiers

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SJM- CIP-CRD 733

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

CRT

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Abbott Medical Devices

Responsible Party

Principal Investigators

Clay Cohorn

Locations

Anhui Provincial Hospital

The second Affliated hospital Anhui Medical University

The second Affiliated hospital of Sun Yat-Sen University

The second hospital of Hebei Medical University

Nanjing Drum Tower Hospital

Jiangsu Province Hospital

Nanjing First Hospital Affiliated to Nanjing Medical University

Zhejiang Greentown cardiovascular hospital

The First Affiliated hospital of Medical College of Zhejiang University

The second Affiliated hospital Zhejiang University School of Medicine

Sir Runrun Shaw Hospital College of Medicine Zhejiang University

Fuwai Hospital CAMS&PUMC

Rui Jin hospital Shanghai Jiao Tong University School of Medicine

Zhongshan Hospital Fudan University

Countries

Other Identifiers

SJM- CIP-CRD 733