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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: CRT

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Fuwai Hospital CAMS&PUMC
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Shanghai, China, 200025
    • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230601
      • The second Affliated hospital Anhui Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510235
      • The Second Affiliated Hospital of Sun Yat-sen University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210029
      • Nanjing First Hospital Affiliated to Nanjing Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310003
      • The first affiliated hospital of medical college of zhejiang university
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Greentown Cardiovascular Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Runrun Shaw Hospital College of Medicine Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Effective LV Pacing	The effectiveness endpoint is the number of participants with effective LV pacing compared to the total number of analyzed participants. The following must be met to be considered effective LV pacing: Pacing threshold (immediately after implant): for pacing threshold at a pulse width of 0.5 ms, the voltage must be ≤3.5 Voltage (V) in any LV lead vector.; Pacing stability (pre-discharge, 3 months and 6 months after implant): for pacing threshold at a pulse width of 0.5 ms, the voltage must be ≤6.0V in any LV lead vector.; Pacing impedance (immediately after implant): Impedance value in any LV lead vector must be in the normal range of 200-2000 ohm (Ω).; Table 9: Impedance stability (pre-discharge, 3 months and 6 months after implant): Impedance value in any LV lead vector must be in the normal range of 200-2000Ω.	6 months
The Number of Participants in Each NYHA Functional Class	This secondary objective is to count the number of participants in each NYHA functional class at 6 months; NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms.	6 months
The Intrinsic QRS Duration of Participants	This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SJM- CIP-CRD 733