Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a sub-population of patients with heart failure.
All patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with one of the leads positioned on the His bundle in order to obtain direct His-bundle capture. There will be a 2-month run-in period where the device is not active.
A double-blinded cross-over design will then be employed to investigate the effect of His bundle pacing. Patients will be allocated in random order to six month treatment periods in each of the following two states (1) No pacing; (2) AV optimised direct His-bundle pacing. Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.
126 patients will be needed to detect the expected effect size on the primary endpoint with 90% power. A total of 160 patients will be recruited to allow for patient drop-out.
Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle. This will be performed either at the patient's local hospital or at Imperial College NHS healthcare Trust, no later than 4 months after the patient's screening visit.
All patients will be implanted with a Pacemaker or Implantable cardioverter defibrillator (ICD). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle in order to obtain direct His-bundle capture. If it is not possible to successfully implant a His-bundle lead with selective direct His bundle capture or non-selective capture with < 40ms prolongation of the QRS duration, then a lead will be implanted in a lateral branch of the coronary sinus.
In patients who do not have an indication for an Implantable cardioverter defibrillator (ICD) a second ventricular lead will be implanted in a lateral branch of the coronary sinus. If direct His pacing has not been successfully achieved then a further lead will be positioned at the RV apex. In patients who do have an indication for an Implantable cardioverter defibrillator the ICD lead will be positioned in the right ventricle (either RV apex or RV septum).
AV delay optimisation will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). The BHF (British Heart Foundation) alternation protocol will be used in order to minimise the effect of background noise.
After implantation of the device there will be a 2 month run-in period prior to randomisation, the device will be programmed not to deliver His bundle pacing therapy during this period.(Back up only pacing and defibrillator function will be enabled).
Two months after patients are implanted with their device, patients will be randomised to either receive active pacing treatment or back up only pacing (pacemaker programmed to VVI 30 bpm). After a further 6 months they will be crossed over to the alternative treatment arm. Treatment allocation will be obtained using an Interactive Web Response System (IWRS) programmed with a randomisation schedule provided by the trial statistician. Appropriate blocking will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker: AV optimised, His pacing | Active Comparator | Subjects will remain in this arm for 6 months before being crossed-over. See below intervention details. |
|
| No pacing | No Intervention | Subjects will remain in this arm for 6 months before being crossed-over. The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker: AV optimised, His pacing. | Device | Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Exercise Capacity. | Measured using peak oxygen uptake (VO2). | Baseline, 6 months and 12 months post randomisation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) | Measured during echocardiogram. | Baseline, 6 months and 12 months post randomisation. |
| Changes in B-type Naturietic Peptide (BNP). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zachary Whinnett, BMBS MRCP | Senior Lecturer, Consultant Cardiologist and Electrophysiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Hertfordshire Hospitals NHS Trust | Watford | Hertfordshire | WD18 0HB | United Kingdom | ||
| Basildon and Thurrock Hospitals NHS Foundation Trust |
All IPD that underlie results in a publication. The data set will be created as an anonymised data sharing package and will be available post publication of data.
6 months post publication of data
The anonymised data set will be shared with the journal in which the papers are published.
We will make the data available for analysis by non-commercial researchers on request to the Chief investigator.
Not provided
Patients have a pacemaker device implanted and are subject to a 2-month run-in phase prior to randomisation.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Pacing Followed by No-Pacing | Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing. See below intervention details. Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 0 (Run-In) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2018 | Sep 28, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation
| Baseline, 6 months and 12 months post randomisation. |
| Changes in Quality of Life Scores. - Minnesota | Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Score range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life | Baseline, 6 months and 12 months post randomisation. |
| Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire) | The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores. NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed | Baseline. |
| Changes in Percentage Pacing | Measured at completion of periods 1 & 2 (M6 & M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms. Results are descriptive and displayed by treatment and by period. | Baseline, 6 months and 12 months post randomisation. |
| Changes in Arrythmia Burden (%). | Measured upon completion of run-in (as baseline) and periods 1 & 2 (M6 & M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period. Results are descriptive and displayed by treatment and by period. | Baseline, 6 months and 12 months post randomisation. |
| Changes in Pacing Thresholds (Volts). | Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12) Results are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead. | Baseline, 6 months and 12 months post randomisation. |
| Changes in R Wave Amplitude. | Measured from electrocardiogram (ECG). | Baseline, 6 months and 12 months post randomisation. |
| Changes in Lead Impedance (Ohms). | Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12). Results are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead. | Baseline, 6 months and 12 months post randomisation. |
| Fluoroscopy Time During Device Insertion. | Measured by time in minutes. | Taken at Device Insertion Visit (2). Baseline measure. |
| Changes in Quality of Life Scores. - EQ5D Health State Score | Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire. Score is on a 0-100 scale with 100 representing a better outcome for patients health state. | Baseline, 6 months and 12 months post randomisation. |
| Basildon |
| United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
| University Hospitals Bristol NHS Foundation Trust | Bristol | United Kingdom |
| Western Sussex Hospitals NHS Foundation Trust | Chichester | United Kingdom |
| Medway NHS Foundation Trust | Gillingham | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Barts Health NHS Trust | London | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | United Kingdom |
| Royal Brompton & Harefield NHS Foundation Trust | London | United Kingdom |
| Papworth Hospital NHS Foundation Trust | Papworth Everard | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | United Kingdom |
| Great Western Hospitals NHS Foundation Trust | Swindon | United Kingdom |
| FG001 | Arm B: No-Pacing Followed by Pacing | Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing. See below intervention details. No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). |
| FG002 | Run-In Phase (Pre-Randomisation) | 2-month run-in period for ALL patients post implantation of pacemaker. Set at No-Pacing. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 1 (Month 0 to Month 6) |
|
| Period 2 (Month 6 to Month 12) |
|
ITT Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Pacing Followed by No-Pacing | Following a lead-in period of No-Pacing subjects will be placed under Direct His bundle pacing before being crossed-over to No-Pacing. See below intervention details. Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. |
| BG001 | Arm B: No-Pacing Followed by Pacing | Following a lead-in period of No-Pacing subjects will be placed under No-Pacing before being crossed-over to Direct His bundle pacing. See below intervention details. No-Pacing: The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. Pacing: AV optimised, His pacing.: Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Diastolic BP | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Systolic BP | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Exercise Capacity. | Measured using peak oxygen uptake (VO2). | ITT | Posted | Mean | 95% Confidence Interval | ml/min/kg | Baseline, 6 months and 12 months post randomisation. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) | Measured during echocardiogram. | ITT Population | Posted | Mean | 95% Confidence Interval | % (LVEF) | Baseline, 6 months and 12 months post randomisation. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in B-type Naturietic Peptide (BNP). | Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation | ITT | Posted | Mean | 95% Confidence Interval | (ng/L) | Baseline, 6 months and 12 months post randomisation. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Quality of Life Scores. - Minnesota | Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Score range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life | ITT - Note that some patients were not able to be analysed due to providing no questionnaire data. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline, 6 months and 12 months post randomisation. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire) | The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores. NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed | NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed | Posted | Baseline. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Percentage Pacing | Measured at completion of periods 1 & 2 (M6 & M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms. Results are descriptive and displayed by treatment and by period. | ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing. | Posted | Mean | Standard Deviation | % (of time over period) | Baseline, 6 months and 12 months post randomisation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Arrythmia Burden (%). | Measured upon completion of run-in (as baseline) and periods 1 & 2 (M6 & M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period. Results are descriptive and displayed by treatment and by period. | ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. | Posted | Mean | Standard Deviation | % (time under AF/SVT burden) | Baseline, 6 months and 12 months post randomisation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Pacing Thresholds (Volts). | Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12) Results are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead. | ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. Outcome is based on when participants are on Pacing therapy and as such a per-protocol analysis would read zero for any period when not on pacing. | Posted | Mean | Standard Deviation | Volts | Baseline, 6 months and 12 months post randomisation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in R Wave Amplitude. | Measured from electrocardiogram (ECG). | Null analysis population as r-wave data was unable to be collected | Posted | Baseline, 6 months and 12 months post randomisation. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Lead Impedance (Ohms). | Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12). Results are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead. | - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint. | Posted | Mean | Standard Deviation | ohms | Baseline, 6 months and 12 months post randomisation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fluoroscopy Time During Device Insertion. | Measured by time in minutes. | ITT - Note that 2 patients (1 in each arm) have missing data. This outcome measure is only based on the device insertion and does not have a cross-over element. | Posted | Median | Inter-Quartile Range | minutes | Taken at Device Insertion Visit (2). Baseline measure. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Quality of Life Scores. - EQ5D Health State Score | Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire. Score is on a 0-100 scale with 100 representing a better outcome for patients health state. | ITT - Note that some patients were not able to be analysed due to providing no questionnaire data. | Posted | Mean | 95% Confidence Interval | scores on a scale | Baseline, 6 months and 12 months post randomisation. |
|
|
AE Data presented was collected during the treatment phase of the study. 12 months in total.
Please note that due to patient withdrawal prior to period 2 (crossover), the total at-risk population for each arm will be lower than 167.
Due to withdrawals by period 2, total at risk for Pacing treatment = 160 Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157
All AEs/SAEs/Mortality events are based on the anticipated treatment being administered during that study period as per randomization arm
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Period (Pre-Randomisation) | 2-month run-in period post device implantation. Device switched to no pacing during this period. | 0 | 167 | 25 | 167 | 54 | 167 |
| EG001 | AV Optimised Direct His-bundle (ARM A at Period 1, ARM B at Period 2) | Adverse Events & Mortality grouped by treatment received over the 12-month follow-up period. AV optimised direct His-bundle (ARM A at Period 1, ARM B at Period 2). Note: Due to withdrawals by period 2, total at risk for Pacing treatment = 160 | 6 | 160 | 25 | 160 | 75 | 160 |
| EG002 | No Pacing (ARM A at Period 2, ARM B at Period 1) | Adverse Events & Mortality grouped by treatment received over the 12-month follow-up period. No Pacing (ARM A at Period 2, ARM B at Period 1) Note: Due to withdrawals by period 2, total at risk for No-Pacing treatment = 157 | 4 | 157 | 20 | 157 | 75 | 157 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Acute pulmonary oedema and Aortic valve stenosis with insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Atrial arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Breathlessness | Cardiac disorders | Systematic Assessment | Exacerbation of heart failure |
| |
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic Shock | Renal and urinary disorders | Systematic Assessment |
| ||
| ICD trigger VF arrest | Cardiac disorders | Systematic Assessment |
| ||
| Community Acquired Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Complete Heart Block | Cardiac disorders | Systematic Assessment |
| ||
| Decompensated / Congestive Cardiac Failure | Cardiac disorders | Systematic Assessment |
| ||
| Exacerbation of Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Ulcerated legs | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fluid overload | Renal and urinary disorders | Systematic Assessment |
| ||
| His Lead displacement | Product Issues | Systematic Assessment |
| ||
| ICD shock | Product Issues | Systematic Assessment |
| ||
| LRTI | Infections and infestations | Systematic Assessment |
| ||
| Haematoma | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaphylactic Reaction | Immune system disorders | Systematic Assessment |
| ||
| Kidney Disease | Renal and urinary disorders | Systematic Assessment | Acute on Chronic Kidney Disease |
| |
| AKI | Renal and urinary disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Raised His Lead Threshold | Cardiac disorders | Systematic Assessment |
| ||
| Subclavian vein thrombosis. | Vascular disorders | Systematic Assessment |
| ||
| VT Episodes | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal blood sugar levels | Endocrine disorders | Systematic Assessment |
| ||
| Abnormal LFTs | Hepatobiliary disorders | Systematic Assessment |
| ||
| Accidental morphine overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Acute Kidney Injury | Endocrine disorders | Systematic Assessment |
| ||
| Ascites | Hepatobiliary disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Baker's cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral numbness of arm when lying either side | Nervous system disorders | Systematic Assessment |
| ||
| Bilateral Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bloatedness | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blocked urethral catheter | Renal and urinary disorders | Systematic Assessment |
| ||
| Cardiac symptoms of palpitations and hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Chest Infection | Infections and infestations | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Common Colds | Infections and infestations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Decompensated Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Diabetic Left Foot Ulcer | Endocrine disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Dry persistent cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Eczema Skin condition | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Exacerbation of HF | Cardiac disorders | Systematic Assessment |
| ||
| Extreme tiredness and fatigue | General disorders | Systematic Assessment |
| ||
| Fall secondary to dizziness | General disorders | Systematic Assessment |
| ||
| Feeling of generally unwell | General disorders | Systematic Assessment |
| ||
| Fever | Infections and infestations | Systematic Assessment |
| ||
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fractured foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Haematuria secondary to NOAC | Renal and urinary disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| HIS lead threshold rise | Cardiac disorders | Systematic Assessment |
| ||
| Hospital Acquired Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Hypergylcaemic Episode | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Idiopathic skin condition | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Impacted ear wax | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Increased breathlessness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Intermittent cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Laceration to big toe | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Left eye vitreous haemorrhage | Eye disorders | Systematic Assessment |
| ||
| Left Kidney Stones | Renal and urinary disorders | Systematic Assessment |
| ||
| Mechanical Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| mouth ulcer requiring biopsy | Gastrointestinal disorders | Systematic Assessment |
| ||
| New diagnosis of diabetes | Endocrine disorders | Systematic Assessment |
| ||
| Non cardiac chest pain | General disorders | Systematic Assessment |
| ||
| nonblanching petechial rashes on both shins | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Non-sustained VT Episodes | Cardiac disorders | Systematic Assessment |
| ||
| Painful bilateral knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| painful lower extremeties | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Paroxysmal Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Polyps in colon | Gastrointestinal disorders | Systematic Assessment |
| ||
| Progressive weight loss | General disorders | Systematic Assessment |
| ||
| Raised His Lead Threshold | Cardiac disorders | Systematic Assessment |
| ||
| Raised INR | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Received external electrical shock at work (works as an electrician) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| recurrence of atrial arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Recurrence of atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Shortness of breath, Productive cough and wheeze due to lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| skin cancer growth L) hand | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Sprained wrist due to fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| stomach pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Suspected lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Sustained VT treated with ATP | Cardiac disorders | Systematic Assessment |
| ||
| swollen abdomen | Hepatobiliary disorders | Systematic Assessment |
| ||
| swollen bilateral legs (knee to ankle) | Cardiac disorders | Systematic Assessment |
| ||
| Swollen feet | Cardiac disorders | Systematic Assessment |
| ||
| Swollen left arm secondary to blood clot | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thyroid Deficiency | Endocrine disorders | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Ventricular Tachycardia Episodes | Cardiac disorders | Systematic Assessment |
| ||
| Viral Illness of unknown origin | Infections and infestations | Systematic Assessment |
| ||
| Weight loss and dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Worsening chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Worsening renal function | Renal and urinary disorders | Systematic Assessment |
| ||
| worsening shortness of breath and activity tolerance | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shortness of breath secondary to bilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| LRTI | Infections and infestations | Systematic Assessment |
| ||
| Anterior L1 Compression Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Barrett's Oesophagus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bilateral swollen and painful legs | Cardiac disorders | Systematic Assessment |
| ||
| Broken rib | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cataracts operation on left eye | Surgical and medical procedures | Systematic Assessment |
| ||
| Coronary Sinus lead displaced | Product Issues | Systematic Assessment |
| ||
| decreased activity tolerance and increased paroxysmal nocturnal dyspnea | Cardiac disorders | Systematic Assessment |
| ||
| Degenerated rotator cuff and tendinopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Dislocated R shoulder due to mechanical fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Excessive intestinal gas -belching or flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fainting spells | General disorders | Systematic Assessment |
| ||
| Fall. Walking sticks slipped off. | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fracture in left elbow due to a fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
| ||
| Heavily trabeculated bladder with debris in urine noted during flexible cystoscopy | Renal and urinary disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Increased urinary frequency secondary to enlarged prostate | Renal and urinary disorders | Systematic Assessment |
| ||
| insertion of indwelling catheter | Renal and urinary disorders | Systematic Assessment |
| ||
| Intermittent high impedance on His Lead with increase in His pacing threshold | Cardiac disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Late His Lead threshold rise | Cardiac disorders | Systematic Assessment |
| ||
| Left leg cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Left lower leg blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| left ventricular thrombus | Cardiac disorders | Systematic Assessment |
| ||
| Lesion in caecum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Marked deterioration of kidney function | Renal and urinary disorders | Systematic Assessment |
| ||
| Mild Infective Exacerbation of Bronchiectasis | Infections and infestations | Systematic Assessment |
| ||
| MRSA positive nose and groin | Infections and infestations | Systematic Assessment |
| ||
| Non-tender pain free lump increasing in size | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Systematic Assessment |
| ||
| Productive cough | Infections and infestations | Systematic Assessment |
| ||
| Recurrent Falls secondary to hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Progressive worsening of breathlessness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Reduced mobility | General disorders | Systematic Assessment |
| ||
| Right leg cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Shoulder joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sinus node dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Sleep Apnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Slight palpitations, Chest discomfort. | Cardiac disorders | Systematic Assessment |
| ||
| ST elevation on ECG post MVO2 | Cardiac disorders | Systematic Assessment |
| ||
| Swollen right leg ?secondary to blood clot | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| TIA | Cardiac disorders | Systematic Assessment |
| ||
| Tingling sensation in both feet | Nervous system disorders | Systematic Assessment |
| ||
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Vitamin D Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| worsening shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Peptic Ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Endoscopy | Investigations | Systematic Assessment |
| ||
| Haematoma | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Penile pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| URTI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vasovagal episode | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Ectopy burden | Cardiac disorders | Systematic Assessment |
| ||
| Injury due to Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| High atrial lead threshold | Cardiac disorders | Systematic Assessment |
| ||
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension and dizziness | Cardiac disorders | Systematic Assessment |
| ||
| Mixed anaerobes in catheter swab | Investigations | Systematic Assessment |
| ||
| Adverse chest findings following x-ray | Infections and infestations | Systematic Assessment |
| ||
| Nitrites in Urine | Investigations | Systematic Assessment |
| ||
| Pseudomonas in urine | Investigations | Systematic Assessment |
| ||
| Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| serous fluid found in old generator box site | Product Issues | Systematic Assessment |
| ||
| Pleural Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Ectopy burden | Cardiac disorders | Systematic Assessment |
| ||
| Low QRS Duration | Cardiac disorders | Systematic Assessment |
| ||
| Pain and limited mobility in the arm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Zachary I Whinnett | Imperial College London | +44 (0)20 7594 5735 | z.whinnett@imperial.ac.uk |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2020 | Sep 28, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Male |
|
| Black |
|
| Mixed |
|
| Other Ethnic Group |
|
| White |
|
|
|
|
|
| OG001 | ARM B (No Pacing --> Pacemaker: AV Optimised, His Pacing) | Subjects will remain in this arm for 6 months before being crossed-over. The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study. |
|
|
|
|
|
|
|
|
|
|
|
|
|