Heart FailureNCT05829876
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
A study testing High Frequency ECG Mapping and Q-LV Measurement in people with Heart Failure, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- High Frequency ECG Mapping and Q-LV Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Oct 2023to Jul 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines;
- In sinus rhythm;
- NYHA class II, III or IV
- Have reviewed, signed and dated an informed consent.
- Age 18
Who cannot join
- Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance);
- Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
- Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- Incessant ventricular tachyarrhythmia;
- Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
- Correctable valvular disease that is the primary cause of heart failure;
Show all 18Show fewer
- Indication for valve repair or replacement;
- Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
- On transplant waiting list;
- Previous heart transplant;
- Already included in another clinical study that could confound the results of this study;
- Life expectancy less than 1 year;
- Inability to understand the purpose of the study;
- Unavailability for scheduled follow-up or refusal to cooperate;
- Age of less than 18 years;
- Pregnancy;
- Drug addiction or abuse;
- Under guardianship.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham
Birmingham, West Midlands, B15 2GW
Jamie Walton, Bsc (Hons) Cardiac Physiology, 01213712535, jamie.walton@uhb.nhs.uk
Francisco Leyva-Leon, MD, 01213712500, francisco.leyva@uhb.nhs.uk
About this study
Official title: Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
Read the detailed description
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment.
Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function.
The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
- Conditions
- Heart Failure
- Being tested
- High Frequency ECG Mapping, Q-LV Measurement
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency ECG MappingOther
A high frequency ECG map will be performed to assess the optimum left ventricular pacing site.
Q-LV MeasurementOther
Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site.
| Study group | Role | What they receive |
|---|---|---|
| HF-ECG guided LV pacing site optimisation | Experimental | Participants will have the left ventricular pacing site programmed based on the results of HF-ECG mapping to locate the area of latest activation and best pattern of paced resynchronisation. Receives: Other: High Frequency ECG Mapping |
| Q-LV guided LV pacing site optimisation | Active comparator | Participants will have the left ventricular pacing site programmed based on the results of Q-LV measurement to locate the area of latest activation. This is the standard of care method for pacing site optimisation. Receives: Other: Q-LV Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Reverse Remodelling
Absolute difference in left ventricular end systolic volume greater than or equal to 10%
Measured: 6 months
Secondary outcomes (4)
Change in NYHA Class
NYHA Class Assessment
Measured: 6 months
Change in quality of life score
Assessment through Minnesota Living with Heart Failure Questionnaire
Measured: 6 months
Change in left ventricular ejection fraction
Improved left ventricular ejection fraction
Measured: 6 months
Reduction in QRS duration
QRS duration measured on 12 lead ECG
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start31 Oct 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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
- Parallel groups
- Model description
- Participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie Walton, BSc, Principal investigator, University Hospitals Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829876
- Sponsor's protocol ID
- RRK7831
- Status last verified
- Nov 2023
- First submitted
- 13 Apr 2023
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
- ClinicalTrials.gov ID
- NCT05829876
- Acronym / sponsor ID
- RRK7831
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Apr 2023 (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 research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
Detailed description
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment.
Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function.
The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization.
| Arm | Type | Receives |
|---|---|---|
| HF-ECG guided LV pacing site optimisation | Experimental | Other: High Frequency ECG MappingParticipants will have the left ventricular pacing site programmed based on the results of HF-ECG mapping to locate the area of latest activation and best pattern of paced resynchronisation. |
| Q-LV guided LV pacing site optimisation | Active comparator | Other: Q-LV MeasurementParticipants will have the left ventricular pacing site programmed based on the results of Q-LV measurement to locate the area of latest activation. This is the standard of care method for pacing site optimisation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines;
Key exclusion criteria (18 listed)
- Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance);
- Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
- Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
- Incessant ventricular tachyarrhythmia;
- Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks;
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 |
|---|---|---|
| High Frequency ECG MappingA high frequency ECG map will be performed to assess the optimum left ventricular pacing site. | Other | HF-ECG guided LV pacing site optimisation |
| Q-LV MeasurementMeasurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site. | Other | Q-LV guided LV pacing site optimisation |
Primary outcome
Left Ventricular Reverse Remodelling
Time frame: 6 months
Absolute difference in left ventricular end systolic volume greater than or equal to 10%
4 secondary outcomes
Change in NYHA Class
Time frame: 6 months
Change in quality of life score
Time frame: 6 months
Change in left ventricular ejection fraction
Time frame: 6 months
Reduction in QRS duration
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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.
Jamie Walton, BSc principal investigator
University Hospitals Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency ECG Mapping and Q-LV Measurement in people with Heart Failure, run by University Hospital Birmingham 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 18 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Walton, Bsc (01213712535, jamie.walton@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Reverse Remodelling (time frame: 6 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 21 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.