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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:
ClinicalTrials.gov Identifier:
NCT01652248
First Posted: July 30, 2012
Last Update Posted: December 3, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
KK Witte, University of Leeds
  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
Intervention Model: Parallel Assignment
Masking: None (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 KK Witte, University of Leeds:

Primary Outcome Measures:
  • Change in LV ejection fraction [ Time Frame: 6 months ]
    Echocardiographic LV function change


Secondary Outcome Measures:
  • Peak exercise capacity [ Time Frame: 6 months ]

Other Outcome Measures:
  • All-cause hospitalisation or death [ Time Frame: 18 months ]
  • Implant duration and infection rate [ Time Frame: 6 months ]

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
Procedure: Cardiac resynchronisation therapy
Upgrade to CRT at the time of 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 time of generator replacement

  Show Detailed Description

  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:

  • 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
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): NCT01652248


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

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
First Submitted: July 23, 2012
First Posted: July 30, 2012
Last Update Posted: December 3, 2015
Last Verified: December 2015

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

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