Pressure Wire Guided Cardiac Resynchronisation Therapy

Phase 2

• Conditions: Heart Failure
• Interventions: Procedure: Standard CRT Implant; Procedure: Pressure-wire guided CRT implant

• Registration Number: NCT01464502
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-03
• Study Start: 2012-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CRT Implant	Standard CRT Implant	-
Pressure-wire guided CRT Implant	Pressure-wire guided CRT implant	-

Primary Outcome Measures

Name	Time	Method
Change in the proportion of CRT responders at 6 months	6 months
Change in clinical composite score at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Change in echo derived left ventricular ejection fraction (LVEF) at 6 months	6 months
Six month change in 6 minute walk distance	6 months
Procedural complications	6 months
Six month assessment of change in symptoms (Minnesota Living with Heart Failure Questionnaire)	6 months
Six month change in ntProBNP	6 months
Change in echo derived endsystolic volume (ESV) at six months	6 months
Six month difference in mortality	6 months
Difference in procedure duration	One week
Difference in radiation dose	One week
Difference in contrast dose	One week
Change in echo derived enddiastolic colume (EDV) at six months	6 months
Six month change in VO2 max (CPET)	6 months
Six month difference in hospital readmission (days)	6 months
Difference in rates of successful LV lead implantation	One week

Trial Locations

Locations (10)

Hospital Auxolgico; 🇮🇹 Milan, Italy

San Rafaelle Hospital; 🇮🇹 Milan, Italy

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, 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

Medway Maritime Hospital; 🇬🇧 Gillingham, Kent, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom