Pressure Wire Guided Cardiac Resynchronisation Therapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Standard CRT Implant; Procedure: Pressure-wire guided CRT implant

• Study Type: Interventional
• Enrollment (Anticipated): 282
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Hospital Auxolgico
    • Contact: Giovanni Prerego, MD
  • Milan, Italy
    • Recruiting
    • San Rafaelle Hospital
    • Contact: Nicoleta Sora, MD
• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • Queen Elizabeth Hospital Birmingham
    • Contact: Francisco Leyva, MD
  • Bournemouth, United Kingdom
    • Recruiting
    • Royal Bournemouth Hospital
    • Contact: John Paisey
  • London, United Kingdom
    • Recruiting
    • The Heart Hospital
    • Contact: Pier Lambiase, MD
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St. Thomas' NHS Foundation NHS Trust
    • Contact: Manav Sohal, BSc, MBBS; Phone Number: 00447939061486; Email: manav.sohal@gstt.nhs.uk
    • Principal Investigator: Manav Sohal, BSc, MBBS
  • London, United Kingdom
    • Recruiting
    • Queen Elizabeth Hospital Woolwich
    • Contact: Shoaib Hamid, MD
  • Newcastle upon Tyne, United Kingdom
    • Recruiting
    • Freeman Hospital
    • Contact: Janet McCoomb, MD
  • Oxford, United Kingdom
    • Recruiting
    • John Radcliffe Hospital
    • Contact: Tim Betts, MD
  • Kent
    • Gillingham, Kent, United Kingdom
      • Recruiting
      • Medway Maritime Hospital
      • Contact: Shaumik Adhya, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; Cardiac resynchronisation therapy; Acute haemodynamic response; Responder
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 11/LO/1879