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Pressure Wire Guided Cardiac Resynchronisation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Guy's and St Thomas' NHS Foundation Trust
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Manav Sohal, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01464502
First received: October 31, 2011
Last updated: October 20, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
  • Change in clinical composite score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: September 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: October 20, 2014
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014