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Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High Frequency ECG Mapping
Q-LV Measurement
Sponsored by
University Hospital Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines; In sinus rhythm; NYHA class II, III or IV Have reviewed, signed and dated an informed consent. Age 18 Exclusion Criteria: 1. Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance); 2. Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month; 3. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; 4. Incessant ventricular tachyarrhythmia; 5. Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks; 6. Correctable valvular disease that is the primary cause of heart failure; 7. Indication for valve repair or replacement; 8. Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months); 9. On transplant waiting list; 10. Previous heart transplant; 11. Already included in another clinical study that could confound the results of this study; 12. Life expectancy less than 1 year; 13. Inability to understand the purpose of the study; 14. Unavailability for scheduled follow-up or refusal to cooperate; 15. Age of less than 18 years; 16. Pregnancy; 17. Drug addiction or abuse; 18. Under guardianship.

Sites / Locations

  • University Hospitals Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HF-ECG guided LV pacing site optimisation

Q-LV guided LV pacing site optimisation

Arm Description

Participants will have the left ventricular pacing site programmed based on the results of HF-ECG mapping to locate the area of latest activation and best pattern of paced resynchronisation.

Participants will have the left ventricular pacing site programmed based on the results of Q-LV measurement to locate the area of latest activation. This is the standard of care method for pacing site optimisation.

Outcomes

Primary Outcome Measures

Left Ventricular Reverse Remodelling
Absolute difference in left ventricular end systolic volume greater than or equal to 10%

Secondary Outcome Measures

Change in NYHA Class
Change in quality of life score
Assessment through Minnesota Living with Heart Failure Questionnaire
Change in left ventricular ejection fraction
Improved left ventricular ejection fraction
Reduction in QRS duration
QRS duration measured on 12 lead ECG

Full Information

First Posted
April 13, 2023
Last Updated
April 13, 2023
Sponsor
University Hospital Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05829876
Brief Title
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
Official Title
Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The research aims to compare the response of Cardiac Resynchronisation Therapy (CRT) using HF ECG guided or the conventional method of Q-LV measurement guided optimisation for left ventricular, pacing site.
Detailed Description
The study aims to demonstrate that left ventricular (LV) pacing site optimisation using high frequency (HF) ECG improves LV reverse remodeling response to Cardiac Resynchronization Therapy (CRT), compared with Q-LV (Q-wave on the surface ECG to LV Electrogram) measurement after 6 months of treatment. Participants will be implanted with a Cardiac Resynchronisation Therapy device with either pacemaker or defibrillator function. The study is a single-Centre, randomized, prospective trial. One hundred and eighty participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization. The participants will be followed up for a period of 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either the treatment (HF-ECG guided LV pacing site optimisation) or control (Q-LV guided LV pacing site optimisation) arm, employing a 1:1 randomization.
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HF-ECG guided LV pacing site optimisation
Arm Type
Experimental
Arm Description
Participants will have the left ventricular pacing site programmed based on the results of HF-ECG mapping to locate the area of latest activation and best pattern of paced resynchronisation.
Arm Title
Q-LV guided LV pacing site optimisation
Arm Type
Active Comparator
Arm Description
Participants will have the left ventricular pacing site programmed based on the results of Q-LV measurement to locate the area of latest activation. This is the standard of care method for pacing site optimisation.
Intervention Type
Other
Intervention Name(s)
High Frequency ECG Mapping
Intervention Description
A high frequency ECG map will be performed to assess the optimum left ventricular pacing site.
Intervention Type
Other
Intervention Name(s)
Q-LV Measurement
Intervention Description
Measurement of Q wave on 12 lead ECG to LV stimulus to assess optimum left ventricular pacing site.
Primary Outcome Measure Information:
Title
Left Ventricular Reverse Remodelling
Description
Absolute difference in left ventricular end systolic volume greater than or equal to 10%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in NYHA Class
Time Frame
6 months
Title
Change in quality of life score
Description
Assessment through Minnesota Living with Heart Failure Questionnaire
Time Frame
6 months
Title
Change in left ventricular ejection fraction
Description
Improved left ventricular ejection fraction
Time Frame
6 months
Title
Reduction in QRS duration
Description
QRS duration measured on 12 lead ECG
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines; In sinus rhythm; NYHA class II, III or IV Have reviewed, signed and dated an informed consent. Age 18 Exclusion Criteria: 1. Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from single chamber ICD with a fully functional defibrillation lead) not under recall or surveillance); 2. Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month; 3. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; 4. Incessant ventricular tachyarrhythmia; 5. Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Coronary Intervention (PCI) within the past 4 weeks; 6. Correctable valvular disease that is the primary cause of heart failure; 7. Indication for valve repair or replacement; 8. Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months); 9. On transplant waiting list; 10. Previous heart transplant; 11. Already included in another clinical study that could confound the results of this study; 12. Life expectancy less than 1 year; 13. Inability to understand the purpose of the study; 14. Unavailability for scheduled follow-up or refusal to cooperate; 15. Age of less than 18 years; 16. Pregnancy; 17. Drug addiction or abuse; 18. Under guardianship.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Walton, Bsc
Phone
01213712535
Email
jamie.walton@uhb.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Leyva-Leon, MD
Phone
01213712500
Email
francisco.leyva@uhb.nhs.uk
Facility Information:
Facility Name
University Hospitals Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Walton, Bsc (Hons) Cardiac Physiology
Phone
01213712535
Email
jamie.walton@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Francisco Leyva-Leon, MD
Phone
01213712500
Email
francisco.leyva@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Francisco Leyva-Leon, MD
First Name & Middle Initial & Last Name & Degree
Jamie Walton, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.

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