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Pressure Wire Guided Cardiac Resynchronisation Therapy

This study is currently recruiting participants.
Verified April 2017 by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464502
First Posted: November 3, 2011
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial of Cardiac Resynchronisation Therapy Guided by Invasive dP/dT: Radi-CRT Study

Resource links provided by NLM:


Further study details as provided by Manav Sohal, Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Change in the proportion of CRT responders at 6 months [ Time Frame: 6 months ]
  • Change in clinical composite score at 6 months [ Time Frame: 6 months ]

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

Estimated Enrollment: 282
Study Start Date: September 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464502


Contacts
Contact: Manav Sohal, BSc, MBBS 00447939061486 manav.sohal@gstt.nhs.uk
Contact: Christopher Aldo Rinaldi, MBBS, MD aldo.rinaldi@gstt.nhs.uk

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

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
First Submitted: October 31, 2011
First Posted: November 3, 2011
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Manav Sohal, 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