Heart FailureNCT03938090
Optimised MultiSite Pacing Vector Study
A study testing Optimised MultiSite Pacing and Standard biventricular pacing in people with Heart Failure and Left Bundle-Branch Block, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Bundle-Branch Block, Systolic Dysfunction
- What is being tested?
- Optimised MultiSite Pacing and Standard biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2019to 1 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic Heart Failure (NYHA class I-IV) with QRS duration of 150ms or more with left bundle branch block and LVEF of 35% or less despite optimal medical therapy.
- Patients above 18 years of age
- Able to provide informed consent and willing to comply with study requirements
- Intrinsic QRS duration ≥ 150 ms
- Sinus (or atrial paced) rhythm with intact AV conduction (PR interval ≤250 ms)
Who cannot join
- Resting heart rate > 100 bpm
- High degree AV Block (2nd or 3rd degree AV block)
- Documented persistent atrial arrhythmia at the moment of enrolment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
- Patients scheduled for AV node ablation to treat atrial arrhythmias
- Recent (< 3 months) myocardial infarction, catheter ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate CRT programming changes in the opinion of the investigator
- Women who are pregnant or plan to become pregnant during the study course
- Known left ventricular thrombus
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's Hospital, Barts Health NHS Trust
London, EC1A 7BE
About this study
Official title: Multimodality Assessment of Acute and Long Term Response to Optimised MultiSite Pacing Cardiac Resynchronisation (MSP CRT) Devices Compared to Biventricular (BiV) CRT, in Patients With Heart Failure
The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.
This clinical investigation is a single-center, prospective, two-arm, randomized 1:1, crossover study designed to evaluate the effectiveness of Optimized MSP CRT compared to conventional bi-ventricular pacing.
Read more
Data will be collected at enrolment, CRT implant procedure, hospital pre-discharge, one, three and six months post implant. Enrolment data collection will include demographics, cardiovascular history, medication, echocardiography measurements, heart failure quality of life questionnaire and six minute walk test distance.
CRT implant procedure data collection will include implanted system information, lead location and conduction times. The electrical conduction recording procedure will include surface ECG and device electrogram (EGM) recordings during various MSP vector pacing configurations at the time of CRT device implant.
Patients will also undergo simultaneous invasive pressure measurements using a left ventricular pressure wire to allow haemodynamic measurements (dP/dtmax) during various MSP vector pacing configurations.
Optimal MSP programming settings will be determined by the narrowest QRS duration recorded by 12 lead ECG and the greatest change in dP/dtmax by pressure wires study.
In a subgroup of patients (approximately 25 patients), non-invasive electrical activation data will be collected with electrocardiographic imaging (ECGi) within 45 days of the implant procedure.
Patients will then be randomized 1:1 to receive either standard biventricular pacing or Optimized MSP at their one-month follow-up (± 15 days) visit.
At the 3 months (± 15 days) post randomization follow up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. The patients will then undergo cross-over to the alternate randomization group with programming adjusted accordingly.
At the final, 6 months (± 15 days) post randomization follow-up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. This will mark the completion of the study for each patient.
The expected duration of enrolment is 18 months. The total duration of the clinical investigation is expected to be 25 months.
- Being tested
- Optimised MultiSite Pacing, Standard biventricular pacing
- Keywords
- Cardiac Resynchronization Therapy, MultiSite Pacing
- Medical subject headings
- Heart Failure, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised MultiSite PacingDevice
The intervention includes using optimal programming settings with MultiSite pacing configurations via the patient's CRT device. The device in use is the same for each arm, the only changes are the programming settings.
Standard biventricular pacingDevice
Conventional programming settings using biventricular pacing will be used
| Study group | Role | What they receive |
|---|---|---|
| Standard biventricular pacing | Placebo comparator | Cardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings Receives: Device: Standard biventricular pacing |
| Optimised MultiSite Pacing (MSP) | Active comparator | Cardiac resynchronization therapy (CRT) devices will be programmed as per optimal MSP programming settings; determined by greatest change in dP/dtmax and narrowest QRS duration. Receives: Device: Optimised MultiSite Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic clinical response
Response to optimised MSP CRT compared to BiV CRT defined by LV systolic volume reduction of greater than 15% (indicative of "reverse remodelling") at completion of follow up.
Measured: 3 and 6 months post randomization
Secondary outcomes (4)
Acute changes in surface ECG QRS duration and morphology
QRS duration changes with CRT programming optimisation
Measured: Acute change in QRS duration with pacing compared to intrinsic QRS duration, measured during pacing programming protcol at device implant
Acute change in LV dP/dtmax
Changes in LV contractility as assessed by pressure wire
Measured: Acute change in LV dP/dtmax with pacing compared to intrinsic rhythm, measured during pacing programming protcol at device implant
Change in exercise capacity by 6MWT distance
6 minute walk test distance
Measured: Pre-implant, 3 and 6 months post randomization
Change in NYHA functional class
New York Heart Association Functional class
Measured: Pre-implant, 3 and 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Dec 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: Severe delay in getting ethics/R\&D approval, Covid delays in initiating study and enrolment. Lack of fellow support for continuing study. After 3-4 years delay, concepts now
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, prospective, two-arm, randomized 1:1, crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Anthony WC Chow, MBBS BSc MD, Principal investigator, Study Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938090
- Sponsor's protocol ID
- 012604
- Status last verified
- May 2025
- First submitted
- 2 May 2019
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No participant data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Assessment of Acute and Long Term Response to Optimised MultiSite Pacing Cardiac Resynchronisation (MSP CRT) Devices Compared to Biventricular (BiV) CRT, in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT03938090
- Acronym / sponsor ID
- 012604
- Keywords
- Cardiac Resynchronization Therapy, MultiSite Pacing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Severe delay in getting ethics/R\&D approval, Covid delays in initiating study and enrolment. Lack of fellow support for continuing study. After 3-4 years delay, concepts now
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 6 May 2019 (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.
The objective of this clinical investigation is to evaluate the clinical benefits of an MultiSite pacing (MSP) with patient specific left ventricular vector optimization in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.
This clinical investigation is a single-center, prospective, two-arm, randomized 1:1, crossover study designed to evaluate the effectiveness of Optimized MSP CRT compared to conventional bi-ventricular pacing.
Data will be collected at enrolment, CRT implant procedure, hospital pre-discharge, one, three and six months post implant. Enrolment data collection will include demographics, cardiovascular history, medication, echocardiography measurements, heart failure quality of life questionnaire and six minute walk test distance.
CRT implant procedure data collection will include implanted system information, lead location and conduction times. The electrical conduction recording procedure will include surface ECG and device electrogram (EGM) recordings during various MSP vector pacing configurations at the time of CRT device implant.
Patients will also undergo simultaneous invasive pressure measurements using a left ventricular pressure wire to allow haemodynamic measurements (dP/dtmax) during various MSP vector pacing configurations.
Optimal MSP programming settings will be determined by the narrowest QRS duration recorded by 12 lead ECG and the greatest change in dP/dtmax by pressure wires study.
In a subgroup of patients (approximately 25 patients), non-invasive electrical activation data will be collected with electrocardiographic imaging (ECGi) within 45 days of the implant procedure.
Patients will then be randomized 1:1 to receive either standard biventricular pacing or Optimized MSP at their one-month follow-up (± 15 days) visit.
At the 3 months (± 15 days) post randomization follow up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. The patients will then undergo cross-over to the alternate randomization group with programming adjusted accordingly.
At the final, 6 months (± 15 days) post randomization follow-up visit, data collection will include surface ECG, EGMs, echocardiographic parameters and quality of life questionnaire. This will mark the completion of the study for each patient.
The expected duration of enrolment is 18 months. The total duration of the clinical investigation is expected to be 25 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center, prospective, two-arm, randomized 1:1, crossover study
| Arm | Type | Receives |
|---|---|---|
| Standard biventricular pacing | Placebo comparator | Device: Standard biventricular pacingCardiac resynchronization therapy (CRT) devices will be programmed as per standard biventricular pacing settings |
| Optimised MultiSite Pacing (MSP) | Active comparator | Device: Optimised MultiSite PacingCardiac resynchronization therapy (CRT) devices will be programmed as per optimal MSP programming settings; determined by greatest change in dP/dtmax and narrowest QRS duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic Heart Failure (NYHA class I-IV) with QRS duration of 150ms or more with left bundle branch block and LVEF of 35% or less despite optimal medical therapy.
- Patients above 18 years of age
- Able to provide informed consent and willing to comply with study requirements
- Intrinsic QRS duration ≥ 150 ms
- Sinus (or atrial paced) rhythm with intact AV conduction (PR interval ≤250 ms)
Key exclusion criteria (7 listed)
- Resting heart rate > 100 bpm
- High degree AV Block (2nd or 3rd degree AV block)
- Documented persistent atrial arrhythmia at the moment of enrolment or patients not likely to remain in sinus (or atrial paced) rhythm for the duration of the study
- Patients scheduled for AV node ablation to treat atrial arrhythmias
- Recent (< 3 months) myocardial infarction, catheter ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate CRT programming changes in the opinion of the investigator
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 |
|---|---|---|
| Optimised MultiSite PacingThe intervention includes using optimal programming settings with MultiSite pacing configurations via the patient's CRT device. The device in use is the same for each arm, the only changes are the programming settings. | Device | Optimised MultiSite Pacing (MSP) |
| Standard biventricular pacingConventional programming settings using biventricular pacing will be used | Device | Standard biventricular pacing |
Primary outcome
Echocardiographic clinical response
Time frame: 3 and 6 months post randomization
Response to optimised MSP CRT compared to BiV CRT defined by LV systolic volume reduction of greater than 15% (indicative of "reverse remodelling") at completion of follow up.
4 secondary outcomes
Acute changes in surface ECG QRS duration and morphology
Time frame: Acute change in QRS duration with pacing compared to intrinsic QRS duration, measured during pacing programming protcol at device implant
Acute change in LV dP/dtmax
Time frame: Acute change in LV dP/dtmax with pacing compared to intrinsic rhythm, measured during pacing programming protcol at device implant
Change in exercise capacity by 6MWT distance
Time frame: Pre-implant, 3 and 6 months post randomization
Change in NYHA functional class
Time frame: Pre-implant, 3 and 6 months post randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No. No participant data will be shared with other researchers
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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.
Anthony WC Chow, MBBS BSc MD principal investigator
Study Chief Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised MultiSite Pacing and Standard biventricular pacing in people with Heart Failure and Left Bundle-Branch Block, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Echocardiographic clinical response (time frame: 3 and 6 months post randomization). 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 11 May 2025.