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| Name | Class |
|---|---|
| University of Aberdeen | OTHER |
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Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. The most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. However, this is not frequently performed because it is time consuming and requires two skilled operators. In this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger).
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive haemodynamic optimisation | Experimental | Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation |
|
| ECHO optimisation | Active Comparator | Optimization of AV/VV delay using the guideline recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive haemodynamic optimisation | Other | Comparing the method of non-invasive haemodynamic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation | 6 months following the last follow-up of the last patient |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether pressure optimisation is at least equivalent to echo optimisation of flow: in terms resulting size of the heart in terms of quality of life scores in terms of blood marker of heart failure severity | 6 months following the last follow-up of the last patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Darrel Francis | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICCH, Imperial College London | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29778861 | Derived | Whinnett ZI, Sohaib SMA, Mason M, Duncan E, Tanner M, Lefroy D, Al-Obaidi M, Ellery S, Leyva-Leon F, Betts T, Dayer M, Foley P, Swinburn J, Thomas M, Khiani R, Wong T, Yousef Z, Rogers D, Kalra PR, Dhileepan V, March K, Howard J, Kyriacou A, Mayet J, Kanagaratnam P, Frenneaux M, Hughes AD, Francis DP. Multicenter Randomized Controlled Crossover Trial Comparing Hemodynamic Optimization Against Echocardiographic Optimization of AV and VV Delay of Cardiac Resynchronization Therapy: The BRAVO Trial. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1407-1416. doi: 10.1016/j.jcmg.2018.02.014. Epub 2018 May 16. | |
| 27411361 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 4, 2019 | |
| Reset | Aug 14, 2019 | |
| Release | Aug 20, 2019 | |
| Reset | Sep 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 4, 2019 | Aug 14, 2019 | |||
| Aug 20, 2019 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ECHO optimisation | Other | Standard ECHO optimisation method |
|
| Derived |
| Jones S, Lumens J, Sohaib SMA, Finegold JA, Kanagaratnam P, Tanner M, Duncan E, Moore P, Leyva F, Frenneaux M, Mason M, Hughes AD, Francis DP, Whinnett ZI; BRAVO Investigators. Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function. Europace. 2017 Jul 1;19(7):1178-1186. doi: 10.1093/europace/euw136. |
| 24693953 | Derived | Whinnett ZI, Sohaib SM, Jones S, Kyriacou A, March K, Coady E, Mayet J, Hughes AD, Frenneaux M, Francis DP; BRAVO Investigators. British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints. BMC Cardiovasc Disord. 2014 Apr 3;14:42. doi: 10.1186/1471-2261-14-42. |
| 24068445 | Derived | Jones S, Shun-Shin MJ, Cole GD, Sau A, March K, Williams S, Kyriacou A, Hughes AD, Mayet J, Frenneaux M, Manisty CH, Whinnett ZI, Francis DP. Applicability of the iterative technique for cardiac resynchronization therapy optimization: full-disclosure, 50-sequential-patient dataset of transmitral Doppler traces, with implications for future research design and guidelines. Europace. 2014 Apr;16(4):541-50. doi: 10.1093/europace/eut257. Epub 2013 Sep 25. |
| Sep 20, 2019 |