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

Chronic Heart Failure Clinical Trial

— MVLV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367716
• Other study ID #: SJM- CIP-CRD 733
• Status: Completed
• Start date: December 2014
• Est. completion date: March 2017

Study information

• Verified date: November 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Fuwai Hospital CAMS&PUMC	Beijing
China	The second Affiliated hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Runrun Shaw Hospital College of Medicine Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang
China	The second Affiliated hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Greentown cardiovascular hospital	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The second Affliated hospital Anhui Medical University	Hefei	Anhui
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Rui Jin hospital Shanghai Jiao Tong University School of Medicine	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	The second hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 (O).; 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 200-2000O.	6 months
Secondary	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
Secondary	The Intrinsic QRS Duration of Participants	This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.	6 months