Heart FailureNCT03567096
LV Only MPP With SyncAV
A study testing BiV pacing with MPP and SyncAV and LV only pacing with MPP and SyncAV in people with Heart Failure and Left Bundle-Branch Block, run by Abbott Medical Devices at 6 sites in 4 countries.
Trial summary
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) 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
- What is being tested?
- BiV pacing with MPP and SyncAV and LV only pacing with MPP and SyncAV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 9 Oct 2018to 30 Sep 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
- Patients with approved indication for CRT scheduled to be implanted with an MPP-enabled ABT Quadripolar CRT pacing system, de novo or upgrade from non-CRT system
- Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements
- Documented permanent left bundle branch block (LBBB)
- Intrinsic QRS duration ≥ 150 ms
- Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
Who cannot join
- Resting heart rate > 100 bpm
- AV Block (1st degree with PR> 250 ms, 2nd or 3rd degree)
- Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment 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 paroxysmal atrial arrhythmias
- Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for CRT programming changes in the opinion of the investigator
- Women who are pregnant or plan to become pregnant during the study course
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United Kingdom3 sites
Queen Elizabeth Hospital
Birmingham
St. Bartholomew's Hospital
London
John Radcliffe Hospital
Oxford
About this study
Official title: Characterization of Acute and Long Term Response to Left Ventricle Only Pacing Combined With MultiPoint Pacing and SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.
This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects.
Read more
Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs.
In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure.
Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire.
Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Being tested
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Keywords
- Cardiac resynchronization therapy, MultiPoint 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.
BiV pacing with MPP and SyncAVDevice
This cohort will receive Bi-Ventricular Pacing (left ventricle and right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.
LV only pacing with MPP and SyncAVDevice
This cohort will receive left ventricular only pacing (no right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.
| Study group | Role | What they receive |
|---|---|---|
| BiV+MPP | Active comparator | Patients randomized to the "BiV pacing with MPP and SyncAV" study arm will have CRT programming to biventricular pacing with MPP activated. RV-LV pacing delay set to 5 ms, LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest QRS duration). Receives: Device: BiV pacing with MPP and SyncAV |
| LV-only + MPP | Experimental | Patients randomized to the " LV only pacing with MPP and SyncAV" study arm will have CRT programming to left ventricular only pacing with MPP activated. LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest QRS duration) Receives: Device: LV only pacing with MPP and SyncAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Patient clinical response to LV only pacing with SyncAV optimization at six-month follow-up evaluated by the Packer clinical composite score.
Measured: up to 6 months
Secondary outcomes (2)
Left Ventricle reverse remodeling
Patient reverse remodeling response to LV only pacing at six-month follow-up defined as end-systolic volume reduction >15%.
Measured: up to 6 months
Electrical resynchronization
Acute changes in surface ECG QRS duration resulting from various CRT and SyncAV pacing configurations.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start9 Oct 2018
- Primary completion24 Feb 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, two-arm, randomized 1:1, multicenter study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Bernarnd Thibault, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567096
- Sponsor's protocol ID
- SJM-CIP-10231
- Status last verified
- Feb 2025
- First submitted
- 25 May 2018
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No participant data will be shared to other researchers
Publications
Thibault B, Waddingham P, Badie N, Mangual JO, Richer LP, McSpadden LC, Betts TR, Calo L, Grieco D, Leyva F, Chow A. Left Ventricular and Biventricular Multipoint Pacing With Dynamic Atrioventricular Delays: 6-Month Cardiac Resynchronization Therapy Response. J Cardiovasc Electrophysiol. 2026 Apr;37(4):811-819. doi: 10.1111/jce.70294. Epub 2026 Feb 26.
PubMed 41755392Thibault B, Waddingham P, Badie N, Mangual JO, McSpadden LC, Betts TR, Calo L, Grieco D, Leyva F, Chow A. Acute Electrical Synchronization Achieved With Dynamic Atrioventricular Delays During Biventricular and Left Ventricular MultiPoint Pacing. CJC Open. 2024 Nov 8;7(2):166-175. doi: 10.1016/j.cjco.2024.11.003. eCollection 2025 Feb.
PubMed 40060211
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Acute and Long Term Response to Left Ventricle Only Pacing Combined With MultiPoint Pacing and SyncAV
- ClinicalTrials.gov ID
- NCT03567096
- Acronym / sponsor ID
- SJM-CIP-10231
- Conditions
- Heart Failure, Left Bundle-Branch Block
- Keywords
- Cardiac resynchronization therapy, MultiPoint Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 25 Jun 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.
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy (CRT) after 6 months of therapy.
This clinical investigation is a prospective, two-arm, randomized 1:1, multicenter feasibility study designed to evaluate the effectiveness of LV only with multipoint pacing (MPP) and SyncAV compared to bi-ventricular pacing with MPP and SyncAV. The clinical investigation will be conducted at approximately 7 centers in Europe and Canada. Approximately 120 subjects will be enrolled in the study. No site may enroll more than 33% of the total subjects.
Data will be collected at enrollment, CRT implant procedure, hospital pre-discharge, one and 6 months post implant. Enrollment data collection will include demographics, cardiovascular history, medication, echocardiography measurements and quality of life questionnaire. CRT implant procedure data collection will include implanted system information and lead location. The electrical conduction recording procedure will include surface ECG and device IEGM recordings during various pacing configurations at implant or up to 45 days post implant. In patients who consent to invasive measurements (expected target of at least 80 patients), a hemodynamic recording procedure will include invasive hemodynamic measurements during various pacing configurations which may take place during device implant or up to 45 days post implant. Hospital pre-discharge data collection will take place within 3 days after the CRT implant, electrical conduction recordings visit or hemodynamic recordings visit and will include system information, surface ECG, and device IEGMs.
In a subset of patients from selected centers that have access to this technology (expected 20 patients), non-invasive electrical activation data will be collected with body surface mapping within 45 days of the implant procedure.
Patients will be randomized 1:1 to receive either biventricular pacing with multipoint pacing (MPP) or LV-only pacing with MPP at the one-month (± 15 days) visit. The 6-month (± 15 days) post randomization follow up visit will include surface ECG, IEGMs, echocardiographic parameters and quality of life questionnaire.
Subjects participating in this clinical investigation will follow the hospital center standard of care from implant to 6 month follow up. The expected duration of enrollment is 1.5 year. The total duration of the clinical investigation is expected to be 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, two-arm, randomized 1:1, multicenter study
| Arm | Type | Receives |
|---|---|---|
| BiV+MPP | Active comparator | Device: BiV pacing with MPP and SyncAVPatients randomized to the "BiV pacing with MPP and SyncAV" study arm will have CRT programming to biventricular pacing with MPP activated. RV-LV pacing delay set to 5 ms, LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest QRS duration). |
| LV-only + MPP | Experimental | Device: LV only pacing with MPP and SyncAVPatients randomized to the " LV only pacing with MPP and SyncAV" study arm will have CRT programming to left ventricular only pacing with MPP activated. LV1 \& LV2 pacing cathodes selected as the maximal spaced electrodes (D1+P4, D2+M3, M2+P4) with pacing delay set to 5 ms and SyncAV offset programmed providing the optimum electrical resynchronization (shortest 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)
- Patients with approved indication for CRT scheduled to be implanted with an MPP-enabled ABT Quadripolar CRT pacing system, de novo or upgrade from non-CRT system
- Patient must be > 18 years of age, able to provide informed consent and willing to comply with study requirements
- Documented permanent left bundle branch block (LBBB)
- Intrinsic QRS duration ≥ 150 ms
- Sinus (or atrial paced) rhythm with intact AV conduction with PR interval ≤ 250 ms
Key exclusion criteria (6 listed)
- Resting heart rate > 100 bpm
- AV Block (1st degree with PR> 250 ms, 2nd or 3rd degree)
- Documented persistent atrial tachycardia or atrial fibrillation at the moment of enrollment 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 paroxysmal atrial arrhythmias
- Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for 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 |
|---|---|---|
| BiV pacing with MPP and SyncAVThis cohort will receive Bi-Ventricular Pacing (left ventricle and right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active. | Device | BiV+MPP |
| LV only pacing with MPP and SyncAVThis cohort will receive left ventricular only pacing (no right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active. | Device | LV-only + MPP |
Primary outcome
Clinical response
Time frame: up to 6 months
Patient clinical response to LV only pacing with SyncAV optimization at six-month follow-up evaluated by the Packer clinical composite score.
2 secondary outcomes
Left Ventricle reverse remodeling
Time frame: up to 6 months
Electrical resynchronization
Time frame: intraoperative
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 21 Feb 2025.
- Derived from this study: PubMed 41755392Thibault B, Waddingham P, Badie N, Mangual JO, Richer LP, McSpadden LC, Betts TR, Calo L, Grieco D, Leyva F, Chow A. Left Ventricular and Biventricular Multipoint Pacing With Dynamic Atrioventricular Delays: 6-Month Cardiac Resynchronization Therapy Response. J Cardiovasc Electrophysiol. 2026 Apr;37(4):811-819. doi: 10.1111/jce.70294. Epub 2026 Feb 26.
- Derived from this study: PubMed 40060211Thibault B, Waddingham P, Badie N, Mangual JO, McSpadden LC, Betts TR, Calo L, Grieco D, Leyva F, Chow A. Acute Electrical Synchronization Achieved With Dynamic Atrioventricular Delays During Biventricular and Left Ventricular MultiPoint Pacing. CJC Open. 2024 Nov 8;7(2):166-175. doi: 10.1016/j.cjco.2024.11.003. eCollection 2025 Feb.
- Individual participant dataSharing planned: No. No participant data will be shared to 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.
Bernarnd Thibault, MD principal investigator
Montreal Heart Institute
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiV pacing with MPP and SyncAV and LV only pacing with MPP and SyncAV in people with Heart Failure and Left Bundle-Branch Block, run by Abbott Medical Devices at 6 sites in 4 countries.
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 6 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Canada, France, Italy. 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?
Clinical response (time frame: up to 6 months). 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 NCT03567096, which also lists 2 linked publications.
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 21 Feb 2025.