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
  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.

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
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: 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
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014