Heart FailureMAPPLENCT03215849
Pacing in Heart Failure With Preserved LVEF
A study testing CRT-pacemaker device set to Routine Medical Therapy, CRT-pacemaker device set to Routine Medical Therapy + LVP and CRT-pacemaker device set to Routine Medical Therapy + BiVP in people with Heart Failure, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes. The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board [CVUHB]). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT-pacemaker device set to Routine Medical Therapy, CRT-pacemaker device set to Routine Medical Therapy + LVP and CRT-pacemaker device set to Routine Medical Therapy + BiVP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2023to 3 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
- LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
- Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
- Adults (over 18 years)
- Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
- Two weeks or more following final dose of vaccination against coronavirus.
Who cannot join
- Inability to provide informed consent.
- Enrolment in other clinical studies.
- BMI more than 35
- Objective evidence of significant lung disease on formal lung function testing
- Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
- Acute coronary syndrome (within the previous three months)
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- History of atrial fibrillation (AF)
- Renal insufficiency requiring haemodialysis
- Life expectancy less than 6 months
- Prosthetic heart valves
- Blood coagulation disorders
- Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
- Currently pregnant, or intending to conceive.
- Recent positive Covid test (up to 14 days prior to pre-assessment).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Wales
Cardiff, Cardiff, CF14 4UJ
About this study
Official title: The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.
The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board [CVUHB]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.
All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:
Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
- Conditions
- Heart Failure
- Being tested
- CRT-pacemaker device set to Routine Medical Therapy, CRT-pacemaker device set to Routine Medical Therapy + LVP, CRT-pacemaker device set to Routine Medical Therapy + BiVP
- 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-pacemaker device set to Routine Medical TherapyDevice
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
CRT-pacemaker device set to Routine Medical Therapy + LVPDevice
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
CRT-pacemaker device set to Routine Medical Therapy + BiVPDevice
Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
| Study group | Role | What they receive |
|---|---|---|
| Routine Medical Therapy | Sham comparator | Routine Medical Therapy Receives: Device: CRT-pacemaker device set to Routine Medical Therapy |
| Routine Medical Therapy + LVP | Experimental | Routine Medical Therapy + LVP Receives: Device: CRT-pacemaker device set to Routine Medical Therapy + LVP |
| Routine Medical Therapy + BiVP | Experimental | Routine Medical Therapy + BiVP Receives: Device: CRT-pacemaker device set to Routine Medical Therapy + BiVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
Measured: 12 weeks
Secondary outcomes (3)
Change in LV area between rest and exercise across the three pacing states
Measured: 12 weeks
Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states
Measured: 12 weeks
Change in rest and exercise E/E' on echocardiography across the three pacing states
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start20 Jul 2023
- Primary completion3 Jul 2025
- Study completion3 Sep 2025
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Cardiff Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Zaheer Yousef, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215849
- Sponsor's protocol ID
- 203878
- Acronym
- MAPPLE
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2017
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
- ClinicalTrials.gov ID
- NCT03215849
- Acronym / sponsor ID
- MAPPLE / 203878
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, Cardiff Metropolitan University
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 12 Jul 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.
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.
The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff \& Vale University Health Board [CVUHB]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.
All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:
Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Routine Medical Therapy | Sham comparator | Device: CRT-pacemaker device set to Routine Medical TherapyRoutine Medical Therapy |
| Routine Medical Therapy + LVP | Experimental | Device: CRT-pacemaker device set to Routine Medical Therapy + LVPRoutine Medical Therapy + LVP |
| Routine Medical Therapy + BiVP | Experimental | Device: CRT-pacemaker device set to Routine Medical Therapy + BiVPRoutine Medical Therapy + BiVP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
- LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
- Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
- Adults (over 18 years)
- Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
Key exclusion criteria (14 listed)
- Inability to provide informed consent.
- Enrolment in other clinical studies.
- BMI more than 35
- Objective evidence of significant lung disease on formal lung function testing
- Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
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-pacemaker device set to Routine Medical TherapyMedtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy | Device | Routine Medical Therapy |
| CRT-pacemaker device set to Routine Medical Therapy + LVPMedtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP | Device | Routine Medical Therapy + LVP |
| CRT-pacemaker device set to Routine Medical Therapy + BiVPMedtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP | Device | Routine Medical Therapy + BiVP |
Primary outcome
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
Time frame: 12 weeks
3 secondary outcomes
Change in LV area between rest and exercise across the three pacing states
Time frame: 12 weeks
Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states
Time frame: 12 weeks
Change in rest and exercise E/E' on echocardiography across the three pacing states
Time frame: 12 weeks
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 23 Oct 2026.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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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.
Zaheer Yousef principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT-pacemaker device set to Routine Medical Therapy, CRT-pacemaker device set to Routine Medical Therapy + LVP and CRT-pacemaker device set to Routine Medical Therapy + BiVP in people with Heart Failure, run by Cardiff and Vale University Health Board 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 6 inclusion and 14 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 23 Oct 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. 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 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?
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states. (time frame: 12 weeks). 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 23 Oct 2026.