Heart Failure and Reduced Ejection FractionRIPCORD-CRTNCT07430553
Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
A study testing Biventricular pacing, Conduction system pacing and Left bundle optimised cardiac resynchronisation therapy in people with Heart Failure and Reduced Ejection Fraction and Dyssynchrony, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat together (called electrical dyssynchrony). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction, Dyssynchrony
- What is being tested?
- Biventricular pacing, Conduction system pacing and Left bundle optimised cardiac resynchronisation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2025to 24 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 referred/scheduled for a CRT procedure (new implant or upgrade) who have:
- Symptomatic heart failure (NYHA II-IV)
- Reduced ejection fraction (LVEF≤40%)
- Prolonged QRS duration (≥130ms) and left bundle branch block ECG morphology or very prolonged QRS duration (>150ms) and non-left bundle branch block ECG
- Optimal medical therapy for HF
Who cannot join
- Unable to provide informed consent
- <18 years old
- Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, Greater London, W12 0HS
Jack W Samways, MBChB MRes (Merit) MRCP(UK), +44 (0) 20 3311 3311 ext. Ask for JWS, jsamways@ic.ac.uk
Ahran D Arnold, MBBS BSc MSc MRCP PhD, +44 (0) 20 3311 3311 ext. Ask for ADA, ada104@ic.ac.uk
About this study
Official title: Randomised Investigation of Physiological, Conventional and Optimised Resynchronisation Therapy in Heart Failure With Prolonged QRS Duration (RIPCORD-CRT)
The goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat together (called electrical dyssynchrony).
The main aims of the study are:
Read more
To compare the effects of conventional biventricular pacing (BVP), conduction system pacing (CSP) and left-bundle optimised CRT (LOT-CRT) on heart failure symptoms and heart rhythm problems over six months.
To explore how these pacing methods affect heart muscle strength, electrical activity, and overall heart function.
Participants will:
Attend four hospital visits over a six-month period.
At Visit 1, meet a member of the research team to discuss the study and have screening tests to check eligibility. Participants will also have a smartphone app installed and receive training on how to record their daily heart failure symptoms.
At Visit 2, have a CRT pacemaker implanted. The type of pacemaker will be chosen at random, with a 1 in 3 chance of receiving:
- Biventricular pacing (BVP); the current standard treatment
- Conduction system pacing (CSP)
- LOT-CRT (Left-bundle optimised CRT); a combination of both
At Visit 3 (around 12 weeks after implantation) and Visit 4 (6 months after implantation), take part in routine follow-up assessments to check the pacemaker and heart function.
At Visits 2 and 4, also undergo non-invasive electrical mapping tests, including wearing a specialised vest and having a low-dose CT scan of the chest. These tests help researchers understand how the heart's electrical system responds to different pacing methods.
- Being tested
- Biventricular pacing, Conduction system pacing, Left bundle optimised cardiac resynchronisation therapy
- Keywords
- Cardiac resynchronisation therapy, Conduction system pacing, optimised CRT, LOT-CRT, heart failure, dyssynchrony, left bundle branch pacing
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular pacingDevice
Also called BVP
Cardiac resynchronisation therapy with one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus.
Conduction system pacingDevice
Also called Physiological pacing, CSP, Left bundle branch pacing, Left bundle branch area pacing
Cardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle. If direct capture of the conduction system cannot be achieved by conventional clinical criteria, left septal pacing targeted at the left bundle branch area will be accepted.
Left bundle optimised cardiac resynchronisation therapyDevice
Also called LOT-CRT, His bundle optimised cardiac resynchronisation therapy, HOT-CRT
Cardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT).
| Study group | Role | What they receive |
|---|---|---|
| Biventricular pacing | Active comparator | Current standard of care cardiac resynchronisation therapy with biventricular pacing (one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus). Receives: Device: Biventricular pacing |
| Conduction system pacing | Experimental | Cardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle. Receives: Device: Conduction system pacing |
| Left bundle optimised cardiac resynchronisation therapy (LOT-CRT) | Experimental | Cardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT). Receives: Device: Left bundle optimised cardiac resynchronisation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Daily ordinal symptom score with clinical over-rides
Daily ordinal scale with mobile application based assessment of quality of life (using visual analogue scale), with clinical over-rides as detailed below:
- Death
- Intractable symptoms leading to trial exit/unblinding
- Heart failure hospitalisation
- Non-heart failure hospitalisation
- Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device)
- Symptom score (1-600, with 1 representing minimum limitation from patient ascribed heart failure symptom and 600 representing maximum limitation)
Measured: From randomisation to 6-months post device implant
Primary arrhythmia outcome
Ordinal arrhythmia scale using clinical endpoints as detailed below:
- Death
- Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device)
- Sustained ventricular arrhythmia (VA) (>30s of rhythm determined to be ventricular in origin by clinical team on device interrogation)
- Sustained atrial arrhythmia
- Non-sustained VA
- >10% ventricular ectopy on 24h ECG
Measured: From randomisation to 6-months post device implant
Primary contractility outcome
Ordinal contractility scale using clinical endpoints as detailed below:
- Death
- Intractable symptoms leading to trial exclusion/unblinding
- Heart failure hospitalisation
- Non-heart failure hospitalisation
- Left ventricular ejection fraction (measured on transthoracic echocardiogram)
Measured: From randomisation to 6-months post device implant
Secondary outcomes (27)
Rate of death
Death, any cause
Measured: From randomisation up to 36 months, or death from any cause, whichever came first.
Number of participants with intractable symptoms leading to trial exit/unblinding
Intractable symptoms leading to exit of trial considered to be a single event. Symptoms will be assessed routinely at a single remote consultation with a blinded research team member 1-4 months after device implant. If at this visit or after a patient directed consultation, symptoms are felt to have deteriorated after the device implant likely due to the device, the case will be discussed with the blinded principal-investigator to adjudicate. If the conclusion is that the deterioration is device mediated, the patient will be unblinded, exit from the trial and the device will be programmed to whatever is felt to be optimal by the clinical team.
Measured: From randomisation up to 36 months, or intractable symptoms leading to trial exit/unblinding, whichever came first.
Rate of heart failure hospitalisation
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit)
Measured: From randomisation up to 36 months
Rate of non-heart failure hospitalisation
Adjudicated unplanned non-heart failure acute care (hospital admissions or ambulatory service i.e. ambulatory emergency clinic).
Measured: From randomisation up to 36 months
Rate of appropriate implantable cardioverter defibrillator device therapy
Anti-tachycardia pacing or shock delivered by device adjudicated to be appropriate for ventricular arrhythmia
Measured: From randomisation up to 36 months
Daily heart failure symptom score
Bespoke mobile phone application based daily ordinal symptom score. Patients asked to identify their most associated heart failure symptom at the beginning of the study, they then grade that symptom on a 0-600 (non-labelled) continuum rating this symptom's severity for the previous day (0 being not limited at all, 600 being extremely limited).
Measured: From randomisation up to 36 months
Rate of sustained ventricular arrhythmia
Adjudicated sustained arrhythmia suspected to be ventricular in origin of >30s on device interrogation
Measured: From randomisation up to 36 months
Rate of sustained atrial arrhythmia
Adjudicated sustained arrhythmia suspected to be atrial in origin of >30s on device interrogation
Measured: From randomisation up to 36 months
Rate of non-sustained ventricular arrhythmia
Adjudicated non-sustained arrhythmia suspected to be ventricular in origin of <30s on device interrogation
Measured: From randomisation up to 36 months
Number of participants with >10% ventricular ectopy on 24h ECG
Measured: At 12-weeks post implant
Left ventricular ejection fraction (LVEF)
LVEF within group differences
Measured: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Left ventricular repolarisation heterogeneity
Non-invasive epicardial electrical mapping (ECGi) derived left ventricular repolarisation time and left ventricular repolarisation gradient
Measured: From implant to 6-months
Left ventricular activation
Non-invasive epicardial electrical mapping (ECGi) derived left ventricular activation time and left ventricular activation recovery interval
Measured: From implant to 6-months
QT dispersion
Measured from 24h ECG monitors patients are fitted with 12 weeks after device implant
Measured: From randomisation to 6 months post device implant
Left ventricular end diastolic volume (LVEDV)
LVEDV within group differences
Measured: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Left ventricular end systolic volume (LVESV)
LVESV within group differences
Measured: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Six minute walk test
Within group comparison
Measured: From baseline to 6 months post device implantation
Serum B-type natriuretic peptide (BNP)
Within group comparison
Measured: From baseline to 6 months post device implant
Quality of life assessed via HeartQoL questionnaire
14 point questionnaire consisting of Likert scale answers to determine quality of life affected by heart disease. Score between 0-42 with a lower score indicating worse quality of life.
Measured: From baseline to 6 months post device implant
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
12 point questionnaire consisting of Likert scale answers to determine quality of life affected by heart failure. Scores between 12-70 with the lower score suggesting a greater reduction in quality of life and worse symptoms.
Measured: From baseline to 6 months post device implant
Minnesota Living With Hearth Failure Questionnaire (MLWHFQ)
21 point questionnaire consisting of Likert scale answers to determine quality of life affected by heart disease. Scores between 0-125 with a lower score representing a better quality of life.
Measured: From baseline to 6 months post device implant
Heart failure status assessed by New York Heart Association classification
Measured: From baseline to 6 months post device implantation
Device derived patient activity level
Activity levels as measured by the implanted pacemaker generator.
Measured: At 6 months post device implant
Device determined atrial fibrillation burden
Proportion of time rhythm is atrial fibrillation as determined by implanted pacemaker detetection.
Measured: At 6 months post pacemaker implant
Percentage of days outside of the normal range device measured intrathoracic impedance or triggering device warning for fluid status
Taken from device checks at 3 and 6 months. Manufacturer specific defined alerts and intrathoracic normal ranges used, to allow to inter-manufacturer comparisons.
Measured: From implant to 6 months post pacemaker implant
Blinding index
Assessed using Bang Blinding Index (BBI), with patients asked regarding allocated treatment arm at the point of discharge following device implant and again before unblinding at 6 months. Scores will be allocated -1 for stating the incorrect treatment arm, 0 for the patient stating they do not know he treatment arm and +1 for a correctly stating the treatment arm.
Measured: From device implant, to 6 months post device implant
Number of patients with treatment related adverse events
Treatment related adverse events include; device infections (requiring device extraction or hospital admission), need for lead revision or reimplantation, premature generator change within study period, haematoma, pericardial effusion requiring intervention and pneumothorax. Other treatment related adverse events non included in this list, but adjudicated by trial steering committee may also be included.
Measured: From device implant to 36 months post device implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start12 Nov 2025
- Primary completion24 Oct 2028 (estimated)
- Study completion24 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 3-arm parallel (1:1:1) study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Zachary I Whinnett, MBBS, BMedSci, MRCP, PhD, Principal investigator, Imperial College LondonAhran D Arnold, MBBS, BSc, MSc, MRCP, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430553
- Sponsor's protocol ID
- 172375
- Other IDs
- FS/CRTF/25/24768
- Acronym
- RIPCORD-CRT
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Investigation of Physiological, Conventional and Optimised Resynchronisation Therapy in Heart Failure With Prolonged QRS Duration (RIPCORD-CRT)
- ClinicalTrials.gov ID
- NCT07430553
- Acronym / sponsor ID
- RIPCORD-CRT / 172375
- Keywords
- Cardiac resynchronisation therapy, Conduction system pacing, optimised CRT, LOT-CRT, heart failure, dyssynchrony, left bundle branch pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 24 Oct 2028 (estimated)
- Study completion
- 24 Oct 2028 (estimated)
- First posted
- 24 Feb 2026 (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 goal of this clinical trial is to find out which type of specialist pacemaker-known as cardiac resynchronisation therapy (CRT)-works best for people with heart failure and a delay in how the lower chambers of the heart beat together (called electrical dyssynchrony).
The main aims of the study are:
To compare the effects of conventional biventricular pacing (BVP), conduction system pacing (CSP) and left-bundle optimised CRT (LOT-CRT) on heart failure symptoms and heart rhythm problems over six months.
To explore how these pacing methods affect heart muscle strength, electrical activity, and overall heart function.
Participants will:
Attend four hospital visits over a six-month period.
At Visit 1, meet a member of the research team to discuss the study and have screening tests to check eligibility. Participants will also have a smartphone app installed and receive training on how to record their daily heart failure symptoms.
At Visit 2, have a CRT pacemaker implanted. The type of pacemaker will be chosen at random, with a 1 in 3 chance of receiving:
- Biventricular pacing (BVP); the current standard treatment
- Conduction system pacing (CSP)
- LOT-CRT (Left-bundle optimised CRT); a combination of both
At Visit 3 (around 12 weeks after implantation) and Visit 4 (6 months after implantation), take part in routine follow-up assessments to check the pacemaker and heart function.
At Visits 2 and 4, also undergo non-invasive electrical mapping tests, including wearing a specialised vest and having a low-dose CT scan of the chest. These tests help researchers understand how the heart's electrical system responds to different pacing methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm parallel (1:1:1) study
| Arm | Type | Receives |
|---|---|---|
| Biventricular pacing | Active comparator | Device: Biventricular pacingCurrent standard of care cardiac resynchronisation therapy with biventricular pacing (one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus). |
| Conduction system pacing | Experimental | Device: Conduction system pacingCardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle. |
| Left bundle optimised cardiac resynchronisation therapy (LOT-CRT) | Experimental | Device: Left bundle optimised cardiac resynchronisation therapyCardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT). |
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 II-IV)
- Reduced ejection fraction (LVEF≤40%)
- Prolonged QRS duration (≥130ms) and left bundle branch block ECG morphology or very prolonged QRS duration (>150ms) and non-left bundle branch block ECG
- Optimal medical therapy for HF
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- <18 years old
- Pregnant patients (with female patients of childbearing age requiring a negative urine BHCG)
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 |
|---|---|---|
| Biventricular pacingAlso: BVPCardiac resynchronisation therapy with one lead to right ventricular endocardium and one lead to left ventricular epicardium, accessed via the coronary sinus. | Device | Biventricular pacing |
| Conduction system pacingAlso: Physiological pacing, CSP, Left bundle branch pacing, Left bundle branch area pacingCardiac resynchronisation therapy with single lead targeting direct capture of the conduction system. Primary target should be left bundle area, with backup target of His bundle. If direct capture of the conduction system cannot be achieved by conventional clinical criteria, left septal pacing targeted at the left bundle branch area will be accepted. | Device | Conduction system pacing |
| Left bundle optimised cardiac resynchronisation therapyAlso: LOT-CRT, His bundle optimised cardiac resynchronisation therapy, HOT-CRTCardiac resynchronisation therapy delivered by conduction system optimised hybrid configurations. Primary configuration should be conduction system pacing lead targeted at the left bundle area combined with left ventricular epicardial lead accessed via the coronary sinus (LOT-CRT). Backup configuration of conduction system pacing lead targeted at the His bundle combined with left ventricular epicardial lead accessed via the coronary sinus (HOT-CRT). | Device | Left bundle optimised cardiac resynchronisation therapy (LOT-CRT) |
Primary outcome
Primary outcome: Daily ordinal symptom score with clinical over-rides
Time frame: From randomisation to 6-months post device implant
Daily ordinal scale with mobile application based assessment of quality of life (using visual analogue scale), with clinical over-rides as detailed below: 1. Death 2. Intractable symptoms leading to trial exit/unblinding 3. Heart failure hospitalisation 4. Non-heart failure hospitalisation 5. Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device) 6. Symptom score (1-600, with 1 representing minimum limitation from patient ascribed heart failure symptom and 600 representing maximum limitation)
Primary arrhythmia outcome
Time frame: From randomisation to 6-months post device implant
Ordinal arrhythmia scale using clinical endpoints as detailed below: 1. Death 2. Appropriate implantable cardioverter defibrillator therapy (anti-tachycardia pacing or shock, deemed appropriate as per clinical care team interrogating device) 3. Sustained ventricular arrhythmia (VA) (>30s of rhythm determined to be ventricular in origin by clinical team on device interrogation) 4. Sustained atrial arrhythmia 5. Non-sustained VA 6. >10% ventricular ectopy on 24h ECG
Primary contractility outcome
Time frame: From randomisation to 6-months post device implant
Ordinal contractility scale using clinical endpoints as detailed below: 1. Death 2. Intractable symptoms leading to trial exclusion/unblinding 3. Heart failure hospitalisation 4. Non-heart failure hospitalisation 5. Left ventricular ejection fraction (measured on transthoracic echocardiogram)
27 secondary outcomes
Rate of death
Time frame: From randomisation up to 36 months, or death from any cause, whichever came first.
Number of participants with intractable symptoms leading to trial exit/unblinding
Time frame: From randomisation up to 36 months, or intractable symptoms leading to trial exit/unblinding, whichever came first.
Rate of heart failure hospitalisation
Time frame: From randomisation up to 36 months
Rate of non-heart failure hospitalisation
Time frame: From randomisation up to 36 months
Rate of appropriate implantable cardioverter defibrillator device therapy
Time frame: From randomisation up to 36 months
Daily heart failure symptom score
Time frame: From randomisation up to 36 months
Rate of sustained ventricular arrhythmia
Time frame: From randomisation up to 36 months
Rate of sustained atrial arrhythmia
Time frame: From randomisation up to 36 months
Rate of non-sustained ventricular arrhythmia
Time frame: From randomisation up to 36 months
Number of participants with >10% ventricular ectopy on 24h ECG
Time frame: At 12-weeks post implant
Left ventricular ejection fraction (LVEF)
Time frame: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Left ventricular repolarisation heterogeneity
Time frame: From implant to 6-months
Left ventricular activation
Time frame: From implant to 6-months
QT dispersion
Time frame: From randomisation to 6 months post device implant
Left ventricular end diastolic volume (LVEDV)
Time frame: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Left ventricular end systolic volume (LVESV)
Time frame: From baseline echocardiogram (pre device implant) to follow-up echocardiogram (at 6 months)
Six minute walk test
Time frame: From baseline to 6 months post device implantation
Serum B-type natriuretic peptide (BNP)
Time frame: From baseline to 6 months post device implant
Quality of life assessed via HeartQoL questionnaire
Time frame: From baseline to 6 months post device implant
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)
Time frame: From baseline to 6 months post device implant
Minnesota Living With Hearth Failure Questionnaire (MLWHFQ)
Time frame: From baseline to 6 months post device implant
Heart failure status assessed by New York Heart Association classification
Time frame: From baseline to 6 months post device implantation
Device derived patient activity level
Time frame: At 6 months post device implant
Device determined atrial fibrillation burden
Time frame: At 6 months post pacemaker implant
Percentage of days outside of the normal range device measured intrathoracic impedance or triggering device warning for fluid status
Time frame: From implant to 6 months post pacemaker implant
Blinding index
Time frame: From device implant, to 6 months post device implant
Number of patients with treatment related adverse events
Time frame: From device implant to 36 months post device implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zachary I Whinnett, MBBS, BMedSci, MRCP, PhD principal investigator
Imperial College London
Ahran D Arnold, MBBS, BSc, MSc, MRCP, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biventricular pacing, Conduction system pacing and Left bundle optimised cardiac resynchronisation therapy in people with Heart Failure and Reduced Ejection Fraction and Dyssynchrony, run by Imperial College London 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 3 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack W Samways, MBChB, MRes, MRCP (+4420 331 33000, jsamways@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Daily ordinal symptom score with clinical over-rides (time frame: From randomisation to 6-months post device implant). The study lists 3 primary outcomes in all. 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 24 Feb 2026.