R-wave Optimisation in Cardiac Resynchronisation Therapy... | NCT02080000

Studies
R-wave Optimisation in Cardiac Resynchronisation Therapy Study

NCT02080000

Sponsor

The Royal Bournemouth Hospital

Status

Completed

Last Update Posted

Apr 28, 2017Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Heart Failure, Systolic

Interventions

Optimisation of V-V timing using R wave on surface ECG
Standard V-V timing settings

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

Apr 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

Feb 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 4, 2014

First Posted Date

Mar 6, 2014Estimated

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

Apr 27, 2017

Last Update Posted Date

Apr 28, 2017Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optimised V-V timing delay	Experimental	V-V timing delay setting on biventricular pacemaker will be optimised guided by size of R-wave on surface ECG	Other: Optimisation of V-V timing using R wave on surface ECG
Standard V-V timing delay	Active Comparator	Standard settings	Other: Standard V-V timing settings

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optimisation of V-V timing using R wave on surface ECG	Other		Optimised V-V timing delay
Standard V-V timing settings

Measure	Description	Time Frame
Quality of Life Score		3 months

Measure	Description	Time Frame
6 minute hall walk distance		3 months
Left Ventricular End Systolic Volume Index		3 months

Measure	Description	Time Frame
Hospitalisation for any cause		3 months
Hospitalisation for Heart Failure		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria

The patient must have a biventricular pacemaker in situ, implanted for NYHA Class III / IV heart failure syndrome with impaired systolic function.
Implantation indication must have included a left ventricular ejection fraction measured on transthoracic echo of <35% and either
- a QRS duration of >150ms or
- a QRS duration of 120 - 149ms with further evidence of dyssynchrony confirmed by echocardiography.
Participants must have >95% true biventricular pacing over the 1 month before enrolment and throughout the observation period.
The biventricular paced QRS complex morphology in lead V1 of subject's standard 12 lead surface ECG must show an R wave height of < 1mm or <20% of the total QRS deflection with standard LV offset settings applied.
The subject's standard 12 lead surface ECG must show a right bundle branch block pattern in lead V1 during LV only pacing.
The participant must be willing to comply with the protocol requirements including travelling to the Royal Bournemouth Hospital for the attendances required for the study and intend to have their long term device follow up at the Royal Bournemouth Hospital at the time of enrolment.
Provision of informed consent Exclusion criteria
Hypertrophic or restrictive cardiomyopathy
Suspected acute myocarditis
Correctable Valvulopathy
An Acute Coronary Syndrome within the last 3 months
Recent (within the last 3 months) or scheduled coronary revascularisation
Treatment resistant hypertension
Severe obstructive lung disease
Pregnancy at the time of enrolment or a desire to become pregnant during the study period
An inability to walk
Reduced life expectancy not associated with cardiovascular disease (less than 1 year)
Unable to provide informed consent

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

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases