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Completed

NCT Number: NCT02367716

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

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).

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: From implantation to 6 months after implant procedure.

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

Secondary outcomes

  1. The Number of Participants With Effective LV Pacing

    Time frame: 6 months

    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.

  2. The Number of Participants in Each NYHA Functional Class

    Time frame: 6 months

    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.

  3. The Intrinsic QRS Duration of Participants

    Time frame: 6 months

    This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: MVLV

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 20, 2015
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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