Heart FailureNCT03769272
Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting
An observational study of Heart Failure, run by Peter J Pugh.
Trial summary
Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart failure. It is a special pacemaker that consists of three pacing wires, which are implanted in the right upper and bottom chambers of the heart and via a vein on the surface of the main pumping chamber (left bottom chamber). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Measurement of electrical delay during LV lead placement
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HF, LBBB and have been referred for CRT.
Who may be able to join
- LV Ejection Fraction ≤ 35 %
- New York Heart Association class I-IV
- QRS ≥130ms
- Left Bundle Branch Block
- Male or female, aged 18 years or above
- Able to give consent
Who cannot join
- Patients with Atrial Fibrillation
- Unable to give consent
- QRS≤120 ms
- Right Bundle Branch Block
About this study
Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart failure. It is a special pacemaker that consists of three pacing wires, which are implanted in the right upper and bottom chambers of the heart and via a vein on the surface of the main pumping chamber (left bottom chamber). CRT helps by improving co- ordination between the top and the bottom chambers of the heart. By stimulating the heart from the left and right bottom chambers, co-ordination can be restored and heart function as well as symptoms improve. It is known that up to 30-40% of patients of patients undergoing CRT pacemaker implantation do not attain any benefit. Given the inherent risks and costs of pacemaker implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.
It has been suggested that presence of scar tissue in the heart and suboptimal placement of the pacing wire on the top of the main pumping chamber can explain this poor response. The best place to position the pacing wire on the surface of the main pumping chamber is the area that contracts last and it can be identified using ultrasound scan of the heart.
Unfortunately, ultrasound is not always possible to help identifying the best area and only a minority of hospitals are able to use this method. Therefore we aim to investigate alternative ways of positioning the pacing wire in the best possible area of the main pumping heart chamber. Investigators propose to measure electrical signals as an alternative and more effective way in positioning the wire in the most effective area. Investigators aim to look at the relationship between the best area identified by ultrasound scan and by electrical signals and also use electrical signals to avoid areas of scar.
Read the detailed description
Cardiac Resynchronisation Therapy (CRT) reduces both morbidity and mortality in selected patients with left ventricular dysfunction and intraventricular conduction delay who remain symptomatic despite optimal medical therapy.
It is known that up to 30% of patients of patients undergoing CRT implantation do not attain symptomatic benefit . Given the inherent risks and costs of device implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.
Factors associated with a poor outcome include presence of myocardial scar, and suboptimal Left Ventricular (LV) lead placement.
Pacing the LV at the most delayed LV region promotes contractile synchrony resulting in more effective and energetically efficient ejection, geometric remodelling with reduced LV end-systolic volume and improved cardiac function.
Studies using transthoracic echocardiographic (TTE) parameters to target the LV lead positioning have shown that an optimal LV lead position at the site of latest mechanical activation, avoiding low strain amplitude (scar), was associated with superior response to CRT and improved survival that persisted during follow-up.
It remains unclear whether the site of latest mechanical activation is related to the site of latest electrical activation, nor whether sensed electrical signals correspond to sites of scar. The site of latest electrical activation is assessed during CRT implant by measuring electrical activation (LV electrical delay) of the LV at different sites in relation to the first deflection of the QRS complex of the surface electrocardiogram (ECG).
A recent study evaluated the relationship between LV electrical delay and CRT outcomes/ response to CRT and concluded that electrical dyssynchrony was strongly and independently associated with reverse remodelling and led to improvement in the Quality of Life with CRT.
Despite TTE being an effective way of assessing optimal LV lead positioning for identifying mechanical activation, it is expensive, images can be suboptimal and usually requires an extra visit prior to implantation, therefore an intraprocedural way of identifying the optimal areas could be beneficial.
It is not known whether lead position as targeted by imaging methods of mechanical activation corresponds to the site of latest electrical activation, nor whether sensed electrical signals correspond to sites of scar. Investigators are planning to investigate the relationship between the site of latest mechanical activation using TTE and the site of latest electrical activation of the LV; and between scar and sensed electrical signals.
If the area of latest mechanical activation is related to the area of latest electrical activation then this can be an alternative, more convenient and cost effective way of assessing optimal LV lead positioning.
- Conditions
- Heart Failure
- Being tested
- Measurement of electrical delay during LV lead placement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of electrical delay during LV lead placementProcedure or surgery
Measurement of electrical signal in the heart during implantation of CRT, by positioning the lead in different places in the heart.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiographic targeting | Not described | |
| Electrogram targeting | Not described Receives: Procedure: Measurement of electrical delay during LV lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle
The time from onset of depolarisation (Q wave) to sensed electrogram in the left ventricle ("LV") will be measured at various sites over the left ventricular epicardium to build up a map of myocardial electrical activation
Measured: 1 day
Secondary outcomes (1)
Mechanical activation of the left ventricle using echocardiography
The pattern of mechanical activation of the left ventricle will be determined using speckle-tracking echocardiography.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Aug 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter J Pugh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter J Pugh, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769272
- Sponsor's protocol ID
- 227862
- Status last verified
- Jul 2019
- First submitted
- 19 Aug 2018
- Last updated
- 5 Jul 2019
- Results posted
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Left Ventricular Lead Positioning During Cardiac Resynchronisation Therapy; Comparison of Two Methods of Targeting
- ClinicalTrials.gov ID
- NCT03769272
- Acronym / sponsor ID
- 227862
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peter J PughUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 7 Dec 2018 (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.
Cardiac Resynchronisation Therapy (CRT) is a well-known treatment for patients with heart failure. It is a special pacemaker that consists of three pacing wires, which are implanted in the right upper and bottom chambers of the heart and via a vein on the surface of the main pumping chamber (left bottom chamber). CRT helps by improving co- ordination between the top and the bottom chambers of the heart. By stimulating the heart from the left and right bottom chambers, co-ordination can be restored and heart function as well as symptoms improve. It is known that up to 30-40% of patients of patients undergoing CRT pacemaker implantation do not attain any benefit. Given the inherent risks and costs of pacemaker implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.
It has been suggested that presence of scar tissue in the heart and suboptimal placement of the pacing wire on the top of the main pumping chamber can explain this poor response. The best place to position the pacing wire on the surface of the main pumping chamber is the area that contracts last and it can be identified using ultrasound scan of the heart.
Unfortunately, ultrasound is not always possible to help identifying the best area and only a minority of hospitals are able to use this method. Therefore we aim to investigate alternative ways of positioning the pacing wire in the best possible area of the main pumping heart chamber. Investigators propose to measure electrical signals as an alternative and more effective way in positioning the wire in the most effective area. Investigators aim to look at the relationship between the best area identified by ultrasound scan and by electrical signals and also use electrical signals to avoid areas of scar.
Detailed description
Cardiac Resynchronisation Therapy (CRT) reduces both morbidity and mortality in selected patients with left ventricular dysfunction and intraventricular conduction delay who remain symptomatic despite optimal medical therapy.
It is known that up to 30% of patients of patients undergoing CRT implantation do not attain symptomatic benefit . Given the inherent risks and costs of device implantation and maintenance, a reduction in the rate of CRT "non-responders" is an important goal.
Factors associated with a poor outcome include presence of myocardial scar, and suboptimal Left Ventricular (LV) lead placement.
Pacing the LV at the most delayed LV region promotes contractile synchrony resulting in more effective and energetically efficient ejection, geometric remodelling with reduced LV end-systolic volume and improved cardiac function.
Studies using transthoracic echocardiographic (TTE) parameters to target the LV lead positioning have shown that an optimal LV lead position at the site of latest mechanical activation, avoiding low strain amplitude (scar), was associated with superior response to CRT and improved survival that persisted during follow-up.
It remains unclear whether the site of latest mechanical activation is related to the site of latest electrical activation, nor whether sensed electrical signals correspond to sites of scar. The site of latest electrical activation is assessed during CRT implant by measuring electrical activation (LV electrical delay) of the LV at different sites in relation to the first deflection of the QRS complex of the surface electrocardiogram (ECG).
A recent study evaluated the relationship between LV electrical delay and CRT outcomes/ response to CRT and concluded that electrical dyssynchrony was strongly and independently associated with reverse remodelling and led to improvement in the Quality of Life with CRT.
Despite TTE being an effective way of assessing optimal LV lead positioning for identifying mechanical activation, it is expensive, images can be suboptimal and usually requires an extra visit prior to implantation, therefore an intraprocedural way of identifying the optimal areas could be beneficial.
It is not known whether lead position as targeted by imaging methods of mechanical activation corresponds to the site of latest electrical activation, nor whether sensed electrical signals correspond to sites of scar. Investigators are planning to investigate the relationship between the site of latest mechanical activation using TTE and the site of latest electrical activation of the LV; and between scar and sensed electrical signals.
If the area of latest mechanical activation is related to the area of latest electrical activation then this can be an alternative, more convenient and cost effective way of assessing optimal LV lead positioning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echocardiographic targeting | – | – |
| Electrogram targeting | – | Procedure: Measurement of electrical delay during LV lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HF, LBBB and have been referred for CRT.
Key inclusion criteria (6 listed)
- LV Ejection Fraction ≤ 35 %
- New York Heart Association class I-IV
- QRS ≥130ms
- Left Bundle Branch Block
- Male or female, aged 18 years or above
Key exclusion criteria (4 listed)
- Patients with Atrial Fibrillation
- Unable to give consent
- QRS≤120 ms
- Right Bundle Branch 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 |
|---|---|---|
| Measurement of electrical delay during LV lead placementMeasurement of electrical signal in the heart during implantation of CRT, by positioning the lead in different places in the heart. | Procedure or surgery | Electrogram targeting |
Primary outcome
Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle
Time frame: 1 day
The time from onset of depolarisation (Q wave) to sensed electrogram in the left ventricle ("LV") will be measured at various sites over the left ventricular epicardium to build up a map of myocardial electrical activation
1 secondary outcome
Mechanical activation of the left ventricle using echocardiography
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Peter J Pugh.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Q-LV (electrical activation of the left ventricle) at different sites of the left ventricle (time frame: 1 day). 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 5 Jul 2019.