Overview

This trial is active, not recruiting.

Condition chronic heart failure
Treatment crt
Sponsor St. Jude Medical
Start date December 2014
End date February 2017
Trial size 121 participants
Trial identifier NCT02367716, SJM- CIP-CRD 733

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

Measure
The occurrence rate of LV leads related SADE
time frame: from implantation to 6 months after implant procedure.

Eligibility Criteria

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

Additional Information

Official title Post-market Study of Multi-Vector LV Lead Performance in Chinese Patients With Chronic Heart Failure
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.