Heart Failure, SystolicNCT02080000
R-wave Optimisation in Cardiac Resynchronisation Therapy Study
A study testing Optimisation of V-V timing using R wave on surface ECG and Standard V-V timing settings in people with Heart Failure, Systolic, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Optimisation of V-V timing using R wave on surface ECG and Standard V-V timing settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Mar 2016
- 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
- The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function.
- Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of <35% and either
- a QRS duration of >150ms or
- a QRS duration of 120 - 149ms with further evidence of dyssynchrony confirmed by echocardiography.
- Participants must have >95% true biventricular pacing over the 1 month before enrolment and throughout the observation period.
- The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of < 1mm or <20% of the total QRS deflection with standard LV offset settings applied.
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- The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing.
- The participant must be willing to comply with the protocol requirements including travelling to the Royal Bournemouth Hospital for the attendances required for the study and intend to have their long term device follow up at the Royal Bournemouth Hospital at the time of enrolment.
- Provision of informed consent Exclusion criteria
- Hypertrophic or restrictive cardiomyopathy
- Suspected acute myocarditis
- Correctable Valvulopathy
- An Acute Coronary Syndrome within the last 3 months
- Recent (within the last 3 months) or scheduled coronary revascularisation
- Treatment resistant hypertension
- Severe obstructive lung disease
- Pregnancy at the time of enrolment or a desire to become pregnant during the study period
- An inability to walk
- Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
- Unable to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: Use of the R-wave to Optimise VV Delay in Heart Failure Patients Treated With Cardiac Resynchronisation Therapy
The aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. More specifically it is to investigate whether using the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.
- Conditions
- Heart Failure, Systolic
- Being tested
- Optimisation of V-V timing using R wave on surface ECG, Standard V-V timing settings
- Keywords
- Heart Failure, Cardiac Resynchronisation Therapy, Biventricular Pacemaker, Optimisation
- 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.
Optimisation of V-V timing using R wave on surface ECGOther
Standard V-V timing settingsOther
| Study group | Role | What they receive |
|---|---|---|
| Optimised V-V timing delay | Experimental | V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG Receives: Other: Optimisation of V-V timing using R wave on surface ECG |
| Standard V-V timing delay | Active comparator | Standard settings Receives: Other: Standard V-V timing settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Score
Measured: 3 months
Secondary outcomes (2)
6 minute hall walk distance
Measured: 3 months
Left Ventricular End Systolic Volume Index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080000
- Sponsor's protocol ID
- ROC001
- Status last verified
- Apr 2017
- First submitted
- 4 Mar 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the R-wave to Optimise VV Delay in Heart Failure Patients Treated With Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT02080000
- Acronym / sponsor ID
- ROC001
- Conditions
- Heart Failure, Systolic
- Keywords
- Heart Failure, Cardiac Resynchronisation Therapy, Biventricular Pacemaker, Optimisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- 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 aim of this study is to investigate whether the use of a simple feature on the 12 lead electrocardiogram (ECG) to optimise pacemaker device programming can have clinically relevant benefit to patient management. More specifically it is to investigate whether using the R-wave in V1 of the surface ECG to guide the timings between left (LV) and right ventricular (RV) pacing improves response to Cardiac Resynchronisation Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised V-V timing delay | Experimental | Other: Optimisation of V-V timing using R wave on surface ECGV-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG |
| Standard V-V timing delay | Active comparator | Other: Standard V-V timing settingsStandard settings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function.
- Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of <35% and either
- Participants must have >95% true biventricular pacing over the 1 month before enrolment and throughout the observation period.
- The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of < 1mm or <20% of the total QRS deflection with standard LV offset settings applied.
- The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Optimisation of V-V timing using R wave on surface ECG | Other | Optimised V-V timing delay |
| Standard V-V timing settings | Other | Standard V-V timing delay |
Primary outcome
Quality of Life Score
Time frame: 3 months
2 secondary outcomes
6 minute hall walk distance
Time frame: 3 months
Left Ventricular End Systolic Volume Index
Time frame: 3 months
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 28 Apr 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimisation of V-V timing using R wave on surface ECG and Standard V-V timing settings in people with Heart Failure, Systolic, run by The Royal Bournemouth Hospital 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 20 inclusion and 0 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 28 Apr 2017. 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?
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?
Quality of Life Score (time frame: 3 months). 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 28 Apr 2017.