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

NCT02367716 | Completed Results

• 1 other identifier: SJM- CIP-CRD 733
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 14

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).

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs)

  The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants.

  From implantation to 6 months after implant procedure.

Secondary Outcomes (3)

• The Number of Participants With Effective LV Pacing

  6 months

• The Number of Participants in Each NYHA Functional Class

  6 months

• The Intrinsic QRS Duration of Participants

  6 months

Interventions

CRT DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (14)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

The second Affliated hospital Anhui Medical University

Hefei, Anhui, 230601, China

Location

The second Affiliated hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510235, China

Location

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Nanjing First Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Zhejiang Greentown cardiovascular hospital

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

The second Affiliated hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Sir Runrun Shaw Hospital College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

Fuwai Hospital CAMS&PUMC

Beijing, 100037, China

Location

Rui Jin hospital Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Results Point of Contact

• Title: Clay Cohorn, Clinical Program Director
• Organization: Cardiac Rhythm Management, Abbott Medical Devices

clay.cohorn@abbott.com

+19723098087

Study Officials

• Clay Cohorn

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-11

Locations

CN (14)