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Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing (PRE-Empt)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KK Witte, University of Leeds
ClinicalTrials.gov Identifier:
NCT01652248
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker battery has run down, it is easily replaced by a short procedure. In those with heart muscle weakness, who use their pacemaker most of the time (rather than acting just as a back-up) the investigators want to find out if adding a further lead to their pacemaker system improves their heart's function, kidney function and exercise capacity.


Condition Intervention
Left Ventricular Function Systolic Dysfunction
 Procedure: Cardiac resynchronisation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Change in LV ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Echocardiographic LV function change


Secondary Outcome Measures:
  • Peak exercise capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • All-cause hospitalisation or death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Implant duration and infection rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: April 2008
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard generator replacement
Standard generator replacement
Active Comparator: Upgrade to cardiac resynchronisation therapy
Upgrade to CRT at the time of generator replacement
 Procedure: Cardiac resynchronisation therapy
Upgrade to CRT at the tim eof generator replacement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Left ventricular dysfunction < 50%
  • Ability and willingness to sign consent form
  • Dependent upon RV pacing with no reprogramming options

Exclusion Criteria:

  • Severe heart failure symptoms indicated for CRT
  • Other serious life-threatening co-morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652248

Locations
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom, LS16 5AR
Sponsors and Collaborators
University of Leeds
  More Information

No publications provided

Responsible Party: KK Witte, Senior Lecturer and Consultant Cardiologist, University of Leeds
ClinicalTrials.gov Identifier: NCT01652248     History of Changes
Other Study ID Numbers: 08/H1307/47
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Leeds:
Heart failure
Pacemaker
cardiac resynchronization therapy

Additional relevant MeSH terms:
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013