Choosing the Right Pacing Mode in Heart Failure - The CHO... | NCT00875732

Studies
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial

NCT00875732

Sponsor

University of Dundee

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Bi Ventricular Pacing
Right Ventricular Pacing

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Mar 31, 2009

First Posted Date

Apr 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

AChoy, Dr. Anna Maria Choy, University of DundeePrincipal Investigator

Lead Sponsor

University of DundeeOTHER

Collaborators

Name	Class
Chest, Heart and Stroke Association Scotland	OTHER
Abbott Medical Devices	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Biventricular Pacing	Device: Bi Ventricular Pacing
2	Active Comparator	Right Ventricular Pacing	Device: Right Ventricular Pacing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bi Ventricular Pacing	Device		1
Right Ventricular Pacing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
6 minute hall walk test		Baseline, 3, 6, 9 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Endothelial Function		Baseline, 3, 6, 9 and 12 months
Cardiac Output		Baseline, 3, 6, 9 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ninewells Hospital & Medical School		Dundee	UK	DD1 9SY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D001919	Bradycardia
D054537	Atrioventricular Block

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided