Pressure Wire Guided Cardiac Resynchronisation Therapy

Heart Failure Clinical Trial

Official title:

A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01464502
• Other study ID #: 11/LO/1879
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 31, 2011
• Last updated: April 3, 2017
• Start date: September 2012
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Manav Sohal, BSc, MBBS
• Phone: 00447939061486
• Email: manav.sohal[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 282
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Standard CRT Implant

• 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.

Locations

Country	Name	City	State
Italy	Hospital Auxolgico	Milan
Italy	San Rafaelle Hospital	Milan
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Medway Maritime Hospital	Gillingham	Kent
United Kingdom	Guy's and St. Thomas' NHS Foundation NHS Trust	London
United Kingdom	Queen Elizabeth Hospital Woolwich	London
United Kingdom	The Heart Hospital	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	St. Jude Medical

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of CRT responders at 6 months		6 months
Primary	Change in clinical composite score at 6 months		6 months
Secondary	Change in echo derived endsystolic volume (ESV) at six months		6 months
Secondary	Change in echo derived enddiastolic colume (EDV) at six months		6 months
Secondary	Change in echo derived left ventricular ejection fraction (LVEF) at 6 months		6 months
Secondary	Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)		6 months
Secondary	Six month change in 6 minute walk distance		6 months
Secondary	Six month change in VO2 max (CPET)		6 months
Secondary	Six month change in ntProBNP		6 months
Secondary	Six month difference in hospital readmission (days)		6 months
Secondary	Six month difference in mortality		6 months
Secondary	Difference in rates of successful LV lead implantation		One week
Secondary	Difference in procedure duration		One week
Secondary	Difference in radiation dose		One week
Secondary	Difference in contrast dose		One week
Secondary	Procedural complications		6 months