Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPacemaker: 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).
Sponsors
British Heart Foundation
Medtronic
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 or above * Ventricular Ejection Fraction (EF) \< 40%; BNP needs to be ≥250ng/L for patients with EF 36-40% * New York Heart Association (NYHA) class II-IV * PR interval ≥200ms * Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
Exclusion criteria
* Permanent or persistent atrial fibrillation (AF) * Paroxysmal atrial fibrillation with history of sustained AF (more than 24 hours) in the 6 months prior to screening * Patients who are unable to perform cardiopulmonary exercise testing * Other serious medical condition with life expectancy of less than 1 year * Lack of capacity to consent * Pregnancy * Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Exercise Capacity. | Baseline, 6 months and 12 months post randomisation. | Measured using peak oxygen uptake (VO2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in B-type Naturietic Peptide (BNP). | Baseline, 6 months and 12 months post randomisation. | Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation |
| Changes in Quality of Life Scores. - Minnesota | Baseline, 6 months and 12 months post randomisation. | 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 |
| Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire) | Baseline. | 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 |
| Changes in Percentage Pacing | Baseline, 6 months and 12 months post randomisation. | 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. |
| Changes in Arrythmia Burden (%). | Baseline, 6 months and 12 months post randomisation. | 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. |
| Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) | Baseline, 6 months and 12 months post randomisation. | Measured during echocardiogram. |
| Changes in R Wave Amplitude. | Baseline, 6 months and 12 months post randomisation. | Measured from electrocardiogram (ECG). |
| Changes in Lead Impedance (Ohms). | Baseline, 6 months and 12 months post randomisation. | 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. |
| Fluoroscopy Time During Device Insertion. | Taken at Device Insertion Visit (2). Baseline measure. | Measured by time in minutes. |
| Changes in Quality of Life Scores. - EQ5D Health State Score | Baseline, 6 months and 12 months post randomisation. | 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. |
| Changes in Pacing Thresholds (Volts). | Baseline, 6 months and 12 months post randomisation. | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
Patients have a pacemaker device implanted and are subject to a 2-month run-in phase prior to randomisation.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| 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). | 84 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 0 (Run-In) | Adverse Event | 0 | 0 | 1 |
| Period 0 (Run-In) | Death | 0 | 0 | 3 |
| Period 0 (Run-In) | Implantation Failure | 0 | 0 | 2 |
| Period 0 (Run-In) | Lost to Follow-up | 0 | 0 | 1 |
| Period 0 (Run-In) | Physician Decision | 0 | 0 | 4 |
| Period 0 (Run-In) | Protocol Violation | 0 | 0 | 1 |
| Period 0 (Run-In) | Withdrawal by Subject | 0 | 0 | 4 |
Baseline characteristics
| Characteristic | Arm A: Pacing Followed by No-Pacing | Arm B: No-Pacing Followed by Pacing | Total |
|---|---|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 9.03 | 68.0 years STANDARD_DEVIATION 10.19 | 69.0 years STANDARD_DEVIATION 9.66 |
| BMI | 28.498 kg/m^2 STANDARD_DEVIATION 5.0208 | 29.665 kg/m^2 STANDARD_DEVIATION 5.5027 | 29.085 kg/m^2 STANDARD_DEVIATION 5.2853 |
| Diastolic BP | 69.0 mmHg STANDARD_DEVIATION 11.22 | 70.8 mmHg STANDARD_DEVIATION 11.31 | 69.9 mmHg STANDARD_DEVIATION 11.26 |
| Race/Ethnicity, Customized Ethnicity Asian | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Other Ethnic Group | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity White | 68 Participants | 69 Participants | 137 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 74 Participants | 77 Participants | 151 Participants |
| Systolic BP | 121.3 mmHg STANDARD_DEVIATION 19.07 | 121.7 mmHg STANDARD_DEVIATION 20.24 | 121.5 mmHg STANDARD_DEVIATION 19.61 |
| Weight | 85.22 kg STANDARD_DEVIATION 16.788 | 89.24 kg STANDARD_DEVIATION 17.636 | 87.24 kg STANDARD_DEVIATION 17.286 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 6 / 160 | 4 / 157 |
| other Total, other adverse events | 54 / 167 | 75 / 160 | 75 / 157 |
| serious Total, serious adverse events | 25 / 167 | 25 / 160 | 20 / 157 |
Outcome results
Primary
Changes in Exercise Capacity.
Measured using peak oxygen uptake (VO2).
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacing | Changes in Exercise Capacity. | 14.0 ml/min/kg |
| No-Pacing | Changes in Exercise Capacity. | 13.7 ml/min/kg |
Comparison: Change in treatment effect taken from mixed-model outputp-value: 0.395% CI: [-0.23, 0.73]Mixed Models Analysis
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.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT - Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pacing | Changes in Arrythmia Burden (%). | BL (Randomisation) | 0.1 % (time under AF/SVT burden) | Standard Deviation 0.52 |
| Pacing | Changes in Arrythmia Burden (%). | M6 | 0.2 % (time under AF/SVT burden) | Standard Deviation 0.62 |
| Pacing | Changes in Arrythmia Burden (%). | M12 | 0.4 % (time under AF/SVT burden) | Standard Deviation 2.01 |
| No-Pacing | Changes in Arrythmia Burden (%). | BL (Randomisation) | 0.3 % (time under AF/SVT burden) | Standard Deviation 2.4 |
| No-Pacing | Changes in Arrythmia Burden (%). | M6 | 0.1 % (time under AF/SVT burden) | Standard Deviation 0.46 |
| No-Pacing | Changes in Arrythmia Burden (%). | M12 | 1.5 % (time under AF/SVT burden) | Standard Deviation 11.87 |
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
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacing | Changes in B-type Naturietic Peptide (BNP). | 323 (ng/L) |
| No-Pacing | Changes in B-type Naturietic Peptide (BNP). | 335 (ng/L) |
Secondary
Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction)
Measured during echocardiogram.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacing | Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) | 33.4 % (LVEF) |
| No-Pacing | Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) | 33.0 % (LVEF) |
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.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: \- Note that results are presented per sequence (e.g, by arm per study period) due to the nature of this particular endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - M6 | 475.2 ohms | Standard Deviation 62.44 |
| Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - M12 | 324.9 ohms | Standard Deviation 87.08 |
| Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - BL | 377.9 ohms | Standard Deviation 104.28 |
| Pacing | Changes in Lead Impedance (Ohms). | LV Lead Impedance - BL | 436.5 ohms | Standard Deviation 90.85 |
| Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - M12 | 452.0 ohms | Standard Deviation 68.38 |
| Pacing | Changes in Lead Impedance (Ohms). | LV Lead Impedance - M6 | 427.8 ohms | Standard Deviation 87.01 |
| Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - M6 | 326.3 ohms | Standard Deviation 84.24 |
| Pacing | Changes in Lead Impedance (Ohms). | LVLead Impedance - M12 | 425.8 ohms | Standard Deviation 85.06 |
| Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - BL | 460.8 ohms | Standard Deviation 66.7 |
| No-Pacing | Changes in Lead Impedance (Ohms). | LVLead Impedance - M12 | 431.2 ohms | Standard Deviation 9.02 |
| No-Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - BL | 480.8 ohms | Standard Deviation 89.24 |
| No-Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - M6 | 469.1 ohms | Standard Deviation 86.48 |
| No-Pacing | Changes in Lead Impedance (Ohms). | RA Lead Impedance - M12 | 473.7 ohms | Standard Deviation 110.6 |
| No-Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - BL | 392.4 ohms | Standard Deviation 97.94 |
| No-Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - M6 | 326.8 ohms | Standard Deviation 87.08 |
| No-Pacing | Changes in Lead Impedance (Ohms). | His Lead Impedance - M12 | 330.6 ohms | Standard Deviation 82.68 |
| No-Pacing | Changes in Lead Impedance (Ohms). | LV Lead Impedance - BL | 464.8 ohms | Standard Deviation 101.62 |
| No-Pacing | Changes in Lead Impedance (Ohms). | LV Lead Impedance - M6 | 439.1 ohms | Standard Deviation 109.44 |
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.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - BL | 0.82 Volts | Standard Deviation 0.972 |
| Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - M6 | 0.82 Volts | Standard Deviation 1.09 |
| Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - M12 | 0.78 Volts | Standard Deviation 1.034 |
| Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - BL | 0.78 Volts | Standard Deviation 0.438 |
| Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - M6 | 0.78 Volts | Standard Deviation 0.452 |
| Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - M12 | 0.78 Volts | Standard Deviation 0.359 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - M6 | 0.73 Volts | Standard Deviation 0.265 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - BL | 0.78 Volts | Standard Deviation 0.51 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - BL | 0.84 Volts | Standard Deviation 0.516 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - M6 | 0.74 Volts | Standard Deviation 0.645 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | LV Lead - M12 | 0.76 Volts | Standard Deviation 0.28 |
| No-Pacing | Changes in Pacing Thresholds (Volts). | RA Lead - M12 | 0.79 Volts | Standard Deviation 0.938 |
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.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pacing | Changes in Percentage Pacing | M6 | 90.8 % (of time over period) | Standard Deviation 19.42 |
| Pacing | Changes in Percentage Pacing | M12 | 1.4 % (of time over period) | Standard Deviation 11.59 |
| No-Pacing | Changes in Percentage Pacing | M6 | 0 % (of time over period) | Standard Deviation 0 |
| No-Pacing | Changes in Percentage Pacing | M12 | 93.5 % (of time over period) | Standard Deviation 16.48 |
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.
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacing | Changes in Quality of Life Scores. - EQ5D Health State Score | 66.3 scores on a scale |
| No-Pacing | Changes in Quality of Life Scores. - EQ5D Health State Score | 64.3 scores on a scale |
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
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: ITT - Note that some patients were not able to be analysed due to providing no questionnaire data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacing | Changes in Quality of Life Scores. - Minnesota | 30.9 scores on a scale |
| No-Pacing | Changes in Quality of Life Scores. - Minnesota | 34.6 scores on a scale |
Secondary
Changes in R Wave Amplitude.
Measured from electrocardiogram (ECG).
Time frame: Baseline, 6 months and 12 months post randomisation.
Population: Null analysis population as r-wave data was unable to be collected
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
Time frame: Baseline.
Population: NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed
Secondary
Fluoroscopy Time During Device Insertion.
Measured by time in minutes.
Time frame: Taken at Device Insertion Visit (2). Baseline measure.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pacing | Fluoroscopy Time During Device Insertion. | 16.5 minutes |
| No-Pacing | Fluoroscopy Time During Device Insertion. | 16.0 minutes |