Heart FailureNCT03071978
Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT Indications
A study testing CRT with LV-only pacing / bi-ventricular pacing in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in China.
Trial summary
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF) population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT with LV-only pacing / bi-ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesChina
- Study dates
- 13 Apr 2017to 29 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18~80
- Life expectancy > 1 year
- Sign Informed Consent
- CRT-indicated
- NYHA (New York Heart Association) class II and III
- PR (term in Electrocardiograph) interval < 200 ms
- ECG (Electrocardiograph) LBBB (left bundle branch block)
Who cannot join
- Patient with severe liver or kidney dysfunction
- CRT-contraindication
- CRT-upgraded
- Persistent AF (atrial fibrillation)
- AV block (atrioventricular block)
- RBBB (right bundle branch block)
Show all 12Show fewer
- Valvular Disease
- LV threshold ≥ 3.5 volt
- Patient is unwilling to sign the informed consent
- Patient is pregnant or has pregnancy intention in the study duration
- Patient has a medical condition that would limit study participation
- Patient is enrolled in a concurrent study that may affect the outcome of this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Fuwai Hospital
Beijing, Beijing Municipality, 010
Greentown Hospital
Hangzhou, Zhejiang, 0571
Jiangsu Province Hospital
Nanjing, Jiangsu, 025
Zhongshan Hospital
Shanghai, Shanghai Municipality, 021
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 0991
About this study
Official title: Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT (Cardiac Resynchronization Therapy) Indications
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy) implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.
Read the detailed description
Traditional dual-chamber pacemakers usually utilize pacing at right atrium (RA) and right ventricle (RV). But many clinical studies have proved that permanent RV pacing could cause ventricular desynchronization in electrical activation and mechanical movement, also may lead to atrial fibrillation and cardiac failure in the long term. Cardiac Resynchronization Therapy (CRT) can overcome the ventricular desynchrony caused by permanent RV pacing, through pacing both left and right ventricles. But the cost of CRT device is usually expensive in emerging markets like in China. Recently, a few clinical studies have demonstrated that LV-fusion pacing (without RV pacing) using adaptive CRT feature provides better clinical outcomes than RV pacing, and also equivalent clinical improvements compared to conventional CRT pacing. However, it is unknown whether similar results can be duplicated in Chinese population as the clinical profile of Chinese CRT populations is different from that of Western CRT population.
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing in Chinese Heart Failure population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.
CRT-indicated heart failure patients who meet the Inclusion \& Exclusion criteria will be enrolled voluntarily in this study. No intervention will be assigned to enrolled patients. CRT therapy will be assigned according to the Guideline (ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012). Left-Ventricular (LV) fusion pacing or Bi-Ventricular (BV) pacing mode, both included in CRT therapy, will be applied upon physicians' judgment based on the Guideline and patients' specific situations. Both pacing modes, as well as all the clinical assessments in this study, are routine cares in clinical practice.
The study will enroll up to 30 subjects in each group (LV pacing group and BV pacing group) that meet the indication for CRT therapy, and also the Inclusion \& Exclusion criteria. Consented subjects will receive CRT therapy and two follow-ups in the following 3 and 6 months.
- Conditions
- Heart Failure
- Being tested
- CRT with LV-only pacing / bi-ventricular pacing
- Keywords
- Heart Failure, LV-fusion pacing, Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT with LV-only pacing / bi-ventricular pacingDevice
LV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm.
| Study group | Role | What they receive |
|---|---|---|
| LV-fusion pacing | Experimental | Left Ventricular pacing (without Right Ventricular pacing) Receives: Device: CRT with LV-only pacing / bi-ventricular pacing |
| BV pacing | Active comparator | Bi-Ventricular pacing Receives: Device: CRT with LV-only pacing / bi-ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
Change of Left Ventricular Ejection Fraction (LVEF) from Baseline to 6-month follow-up
Measured: 6-month follow up after CRT implantation
Secondary outcomes (4)
New York Heart Association (NYHA) class
Change of New York Heart Association (NYHA) class from Baseline to 6-month follow-up
Measured: 6-month follow up after CRT implantation
6-minute walking distance (6MWD)
Change of 6-minute walking distance (6MWD) from Baseline to 6-month follow-up
Measured: 6-month follow up after CRT implantation
ECG QRS duration
Change of ECG QRS duration from Baseline to 6-month follow-up
Measured: 6-month follow up after CRT implantation
echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD)
Change of echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD) from Baseline to 6-month follow-up
Measured: 6-month follow up after CRT implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start13 Apr 2017
- Primary completion8 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan-gang Su, M.D., Principal investigator, ZhongShan Hospital, ShanghaiShu Zhang, M.D., Principal investigator, Fuwai Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071978
- Sponsor's protocol ID
- LV Study
- Status last verified
- Feb 2020
- First submitted
- 23 Jan 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Right Atrial Left Ventricular Fusion Pacing in Patients With CRT (Cardiac Resynchronization Therapy) Indications
- ClinicalTrials.gov ID
- NCT03071978
- Acronym / sponsor ID
- LV Study
- Conditions
- Heart Failure
- Keywords
- Heart Failure, LV-fusion pacing, Cardiac Resynchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing, also known as Cardiac Resynchronization Therapy (CRT), in Chinese Heart Failure (HF) population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT (adaptive Cardiac Resynchronization Therapy) implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.
Detailed description
Traditional dual-chamber pacemakers usually utilize pacing at right atrium (RA) and right ventricle (RV). But many clinical studies have proved that permanent RV pacing could cause ventricular desynchronization in electrical activation and mechanical movement, also may lead to atrial fibrillation and cardiac failure in the long term. Cardiac Resynchronization Therapy (CRT) can overcome the ventricular desynchrony caused by permanent RV pacing, through pacing both left and right ventricles. But the cost of CRT device is usually expensive in emerging markets like in China. Recently, a few clinical studies have demonstrated that LV-fusion pacing (without RV pacing) using adaptive CRT feature provides better clinical outcomes than RV pacing, and also equivalent clinical improvements compared to conventional CRT pacing. However, it is unknown whether similar results can be duplicated in Chinese population as the clinical profile of Chinese CRT populations is different from that of Western CRT population.
This study is designed to assess the clinical outcomes of Left-Ventricular (LV) fusion pacing compared to Bi-Ventricular (BV) pacing in Chinese Heart Failure population. Specifically, the study will assess the changes of cardiac function of each group through 3-month follow up/ 6-month follow up compared with original outcomes before aCRT implantation. Secondly, the study will assess whether parameters of aCRT that were tested in Western population are relevant to parameters of Chinese HF patients.
CRT-indicated heart failure patients who meet the Inclusion \& Exclusion criteria will be enrolled voluntarily in this study. No intervention will be assigned to enrolled patients. CRT therapy will be assigned according to the Guideline (ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012). Left-Ventricular (LV) fusion pacing or Bi-Ventricular (BV) pacing mode, both included in CRT therapy, will be applied upon physicians' judgment based on the Guideline and patients' specific situations. Both pacing modes, as well as all the clinical assessments in this study, are routine cares in clinical practice.
The study will enroll up to 30 subjects in each group (LV pacing group and BV pacing group) that meet the indication for CRT therapy, and also the Inclusion \& Exclusion criteria. Consented subjects will receive CRT therapy and two follow-ups in the following 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LV-fusion pacing | Experimental | Device: CRT with LV-only pacing / bi-ventricular pacingLeft Ventricular pacing (without Right Ventricular pacing) |
| BV pacing | Active comparator | Device: CRT with LV-only pacing / bi-ventricular pacingBi-Ventricular pacing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18~80
- Life expectancy > 1 year
- Sign Informed Consent
- CRT-indicated
- NYHA (New York Heart Association) class II and III
Key exclusion criteria (12 listed)
- Patient with severe liver or kidney dysfunction
- CRT-contraindication
- CRT-upgraded
- Persistent AF (atrial fibrillation)
- AV block (atrioventricular block)
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 |
|---|---|---|
| CRT with LV-only pacing / bi-ventricular pacingLV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm. | Device | BV pacing, LV-fusion pacing |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: 6-month follow up after CRT implantation
Change of Left Ventricular Ejection Fraction (LVEF) from Baseline to 6-month follow-up
4 secondary outcomes
New York Heart Association (NYHA) class
Time frame: 6-month follow up after CRT implantation
6-minute walking distance (6MWD)
Time frame: 6-month follow up after CRT implantation
ECG QRS duration
Time frame: 6-month follow up after CRT implantation
echocardiographic assessments (including LVESV, LVEDV, LVESD, LVEDD)
Time frame: 6-month follow up after CRT implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Yan-gang Su, M.D. principal investigator
ZhongShan Hospital, Shanghai
Shu Zhang, M.D. principal investigator
Fuwai Hospital, Beijing
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT with LV-only pacing / bi-ventricular pacing in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 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 7 inclusion and 12 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left Ventricular Ejection Fraction (LVEF) (time frame: 6-month follow up after CRT implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2020.