Heart FailureNCT01831518
Predicting Response to CRT Using Body Surface ECG Mapping
A study testing CRT Implant and Body Surface ECG Mapping in people with Heart Failure, run by Tom Jackson at 2 sites in United Kingdom.
Trial summary
Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT Implant and Body Surface ECG Mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2014to 1 Jun 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
- Age >18 years old
- Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
- NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
- LVEF <35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
- QRS duration > 130ms
- Optimal Tolerated Medical Therapy for Heart Failure
Who cannot join
- Severe, life threatening non cardiac disease
- Active malignant disease and recent (<5 years) malignant disease
- Prior Heart Transplant
- Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
- Pregnancy
- Failure to participate in consent process
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- Atrial Fibrillation
- Conventional pacemaker in situ
- Heart Failure requiring constant intravenous therapy including diuretics and/or inotropes
- Recent revascularisation procedure i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the last three months
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
The Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
About this study
Official title: Evaluation of a Novel Method of Non-surface Electrocardiographic Mapping in Predicting Clinical, Structural and Neurohormonal Responses in Patients Undergoing Cardiac Resynchronization Therapy.
Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ECG. This study aims to determine whether this new technology may aid current selection criteria in predicting response to CRT.
- Conditions
- Heart Failure
- Being tested
- CRT Implant, Body Surface ECG Mapping
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, ECG Imaging, Body Surface Mapping
- 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 ImplantDevice
Also called Cardiac Resynchronization, Biventricular Pacemaker
Body Surface ECG MappingDevice
Also called ECG Imaging
| Study group | Role | What they receive |
|---|---|---|
| CRT Eligible | Experimental | ACC/AHA/HRS/ESC guidelines for device-based therapy Receives: Device: CRT Implant; Device: Body Surface ECG Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in distance travelled during six-minute walk test (6MWT)
Measured: Baseline and 6 months
Echocardiographic: signs of LV reverse remodelling
Increase by >5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes
Measured: Baseline and 6 months
Secondary outcomes (3)
Symptoms
Change in symptoms severity assessed by Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Measured: Baseline and 6 months
Neurohormonal status
Change in neurohormonal activation assessed by brain-natriuretic peptide (BNP)
Measured: Baseline and 6 Months
Pacing
Atrial and ventricular arrhythmic burden, percentage of bi-ventricular pacing
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 posted15 Apr 2013 (estimated)
- Study startJul 2014
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tom Jackson
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, CardioInsight Technologies, Inc.
- Responsible party
- Sponsor-investigator, Tom Jackson, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831518
- Sponsor's protocol ID
- STHCIT1
- Status last verified
- Oct 2018
- First submitted
- 4 Apr 2013
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jackson T, Claridge S, Behar J, Sieniewicz B, Gould J, Porter B, Sidhu B, Yao C, Lee A, Niederer S, Rinaldi CA. Differential effect with septal and apical RV pacing on ventricular activation in patients with left bundle branch block assessed by non-invasive electrical imaging and in silico modelling. J Interv Card Electrophysiol. 2020 Jan;57(1):115-123. doi: 10.1007/s10840-019-00567-2. Epub 2019 Jun 14.
PubMed 31201592
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Method of Non-surface Electrocardiographic Mapping in Predicting Clinical, Structural and Neurohormonal Responses in Patients Undergoing Cardiac Resynchronization Therapy.
- ClinicalTrials.gov ID
- NCT01831518
- Acronym / sponsor ID
- STHCIT1
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, ECG Imaging, Body Surface Mapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tom JacksonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, CardioInsight Technologies, Inc.
- Study start
- Jul 2014
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 15 Apr 2013 (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.
Cardiac resynchronization therapy (CRT) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. Current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ECG). Unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. Body surface ECG mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ECG. This study aims to determine whether this new technology may aid current selection criteria in predicting response to CRT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT Eligible | Experimental | Device: CRT Implant, Device: Body Surface ECG MappingACC/AHA/HRS/ESC guidelines for device-based therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years old
- Fulfils established clinical criteria for CRT implantation (with or without a defibrillator)
- NYHA Class III-IV Heart Failure (or NYHA II with NYHA III/IV symptoms in the preceding 12 months)
- LVEF <35% (Calculated using echocardiography or Cardiac MR) at the time of implantation
- QRS duration > 130ms
Key exclusion criteria (10 listed)
- Severe, life threatening non cardiac disease
- Active malignant disease and recent (<5 years) malignant disease
- Prior Heart Transplant
- Recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study
- Pregnancy
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 ImplantAlso: Cardiac Resynchronization, Biventricular Pacemaker | Device | CRT Eligible |
| Body Surface ECG MappingAlso: ECG Imaging | Device | CRT Eligible |
Primary outcome
Change in distance travelled during six-minute walk test (6MWT)
Time frame: Baseline and 6 months
Echocardiographic: signs of LV reverse remodelling
Time frame: Baseline and 6 months
Increase by >5% in left ventricular ejection fraction with an associated decrease in LV end-diastolic (LVEDV) and end-systolic (LVESV) volumes
3 secondary outcomes
Symptoms
Time frame: Baseline and 6 months
Neurohormonal status
Time frame: Baseline and 6 Months
Pacing
Time frame: 6 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 5 Oct 2018.
- Derived from this study: PubMed 31201592Jackson T, Claridge S, Behar J, Sieniewicz B, Gould J, Porter B, Sidhu B, Yao C, Lee A, Niederer S, Rinaldi CA. Differential effect with septal and apical RV pacing on ventricular activation in patients with left bundle branch block assessed by non-invasive electrical imaging and in silico modelling. J Interv Card Electrophysiol. 2020 Jan;57(1):115-123. doi: 10.1007/s10840-019-00567-2. Epub 2019 Jun 14.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT Implant and Body Surface ECG Mapping in people with Heart Failure, run by Tom Jackson at 2 sites 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 10 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 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in distance travelled during six-minute walk test (6MWT) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. 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 NCT01831518, which also lists 1 linked publication.
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 5 Oct 2018.