Chronic Heart FailureMVLVNCT02367716

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

An observational study of Chronic Heart Failure, run by Abbott Medical Devices at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Heart Failure
What is being tested?: CRT
Type of treatment: Medical device
How many people: 121 participants
Where: 14 sitesChina
Study dates: Dec 2014to Mar 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: A patient meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

China14 sites

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

Other trials in China

About this study

Read the 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.

Conditions: Chronic Heart Failure
Being tested: CRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRTDevice
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From implantation to 6 months after implant procedure.

Secondary outcomes (3)

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.
Measured: 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.
Measured: 6 months
The Intrinsic QRS Duration of Participants
This secondary objective is to measure the intrinsic QRS duration of participants at 6 months.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Mar 2017

First posted20 Feb 2015 (estimated)
Study startDec 2014
Primary completionOct 2016
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02367716
Sponsor's protocol ID: SJM- CIP-CRD 733
Acronym: MVLV
Status last verified: Nov 2020
First submitted: 12 Feb 2015
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease

All Chronic Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
ClinicalTrials.gov ID: NCT02367716
Acronym / sponsor ID: MVLV / SJM- CIP-CRD 733
Conditions: Chronic Heart Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Dec 2014 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Mar 2017 (actual)
First posted: 20 Feb 2015 (estimated)
Results: Posted 18 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a multi-center, non-randomized observational study.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: A patient meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CRTThe 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	Device	–

Primary outcome

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.

3 secondary outcomes

The Number of Participants With Effective LV Pacing
Time frame: 6 months
The Number of Participants in Each NYHA Functional Class
Time frame: 6 months
The Intrinsic QRS Duration of Participants
Time frame: 6 months

Results and safety

Results posted to the registry on 18 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm- St. Jude Medical Quartet™ LV Lead Model 1458Q	121	120

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

Time frame: From implantation to 6 months after implant procedure.. Count of participants. Unit: Participants

Measure	Treatment Arm of SJM Quartet™ LV Lead Model 1458Q n = 120
Value	2

Population analysed: Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	11 of 120 (9.2%)	2 of 120 (1.7%)	3 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Heart Failure

Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clay Cohorn study director

Abbott

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure, run by Abbott Medical Devices at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) (time frame: From implantation to 6 months after implant procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02367716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.