Pressure Wire Guided Cardiac Resynchronisation Therapy
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Purpose
Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders.
Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure.
If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Procedure: Standard CRT Implant Procedure: Pressure-wire guided CRT implant |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study |
- Change in the proportion of CRT responders at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in clinical composite score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in echo derived endsystolic volume (ESV) at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in echo derived enddiastolic colume (EDV) at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in echo derived left ventricular ejection fraction (LVEF) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month change in 6 minute walk distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month change in VO2 max (CPET) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month change in ntProBNP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month difference in hospital readmission (days) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Six month difference in mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Difference in rates of successful LV lead implantation [ Time Frame: One week ] [ Designated as safety issue: No ]
- Difference in procedure duration [ Time Frame: One week ] [ Designated as safety issue: No ]
- Difference in radiation dose [ Time Frame: One week ] [ Designated as safety issue: No ]
- Difference in contrast dose [ Time Frame: One week ] [ Designated as safety issue: No ]
- Procedural complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 282 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Standard CRT Implant | Procedure: Standard CRT Implant |
| Active Comparator: Pressure-wire guided CRT Implant |
Procedure: Pressure-wire guided CRT implant
A pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients fulfilling standard criteria for CRT
- Ischaemic or non-ischaemic heart failure
Exclusion Criteria:
- Contraindication to pressure wire assessment including:
- Severe aortic valve disease
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
- LV thrombus
Contacts and Locations| Contact: Manav Sohal, BSc, MBBS | 00447939061486 | manav.sohal@gstt.nhs.uk |
| Contact: Christopher Aldo Rinaldi, MBBS, MD | aldo.rinaldi@gstt.nhs.uk |
| United Kingdom | |
| Guy's and St. Thomas' NHS Foundation NHS Trust | Not yet recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Manav Sohal, BSc, MBBS 00447939061486 manav.sohal@gstt.nhs.uk | |
| Principal Investigator: Manav Sohal, BSc, MBBS | |
More Information
No publications provided
| Responsible Party: | Manav Sohal, Research Fellow, Guy's and St Thomas' NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01464502 History of Changes |
| Other Study ID Numbers: | 11/LO/1879 |
| Study First Received: | October 31, 2011 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
|
Heart failure Cardiac resynchronisation therapy Acute haemodynamic response Responder |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013