NCT00875732

Brief Summary

The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function. The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable heart-failure

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

First Submitted

Initial submission to the registry

March 31, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

March 31, 2009

Last Update Submit

July 7, 2017

Conditions

Heart Failure

Keywords

ResynchronizationDeviceBradycardiaatrioventricular blockCardiac Resynchronization

Outcome Measures

Primary Outcomes (1)

  • 6 minute hall walk test

    Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (2)

  • Endothelial Function

    Baseline, 3, 6, 9 and 12 months

  • Cardiac Output

    Baseline, 3, 6, 9 and 12 months

Study Arms (2)

1

EXPERIMENTAL

Biventricular Pacing

Device: Bi Ventricular Pacing

2

ACTIVE COMPARATOR

Right Ventricular Pacing

Device: Right Ventricular Pacing

Interventions

Bi Ventricular PacingDEVICE
1
Right Ventricular PacingDEVICE
2

Eligibility Criteria

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

You may qualify if:

  • Left ventricular systolic dysfunction.
  • Atrio-ventricular node disease.
  • Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).
  • Ability to walk independently (walking aid permitted).

You may not qualify if:

  • Patients meeting criteria for CRT by current guidelines will be excluded.
  • Life expectancy less than12 months.
  • Inability to walk independently.
  • Patients not likely to be compliant with follow-up.
  • Bradyarrhythmia due with sino-atrial disease only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital & Medical School

Dundee, UK, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Heart FailureBradycardiaAtrioventricular Block

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Anna Maria Choy

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 3, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2011

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

GB(1)