NCT01652248

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

July 23, 2012

Last Update Submit

December 1, 2015

Conditions

Left Ventricular Function Systolic Dysfunction

Keywords

Heart failurePacemakercardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • Change in LV ejection fraction

    Echocardiographic LV function change

    6 months

Secondary Outcomes (1)

  • Peak exercise capacity

    6 months

Other Outcomes (2)

  • All-cause hospitalisation or death

    18 months

  • Implant duration and infection rate

    6 months

Study Arms (2)

Standard generator replacement

PLACEBO COMPARATOR

Standard generator replacement

Procedure: Cardiac resynchronisation therapy

Upgrade to cardiac resynchronisation therapy

ACTIVE COMPARATOR

Upgrade to CRT at the time of generator replacement

Procedure: Cardiac resynchronisation therapy

Interventions

Cardiac resynchronisation therapyPROCEDURE

Upgrade to CRT at the time of generator replacement

Standard generator replacementUpgrade to cardiac resynchronisation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Severe heart failure symptoms indicated for CRT
  • Other serious life-threatening co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds General Infirmary

Leeds, LS16 5AR, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer and Consultant Cardiologist

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 30, 2012

Study Start

April 1, 2008

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

GB(1)