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Mechanisms and Innovations in Cardiac Resynchronisation Therapy (MIC)

Primary Purpose

Heart Failure, Left Ventricular Systolic Dysfunction, Left Bundle-Branch Block

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
His-bundle pacing.
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resynchronization therapy, His bundle pacing, Haemodynamics, ECGI

Eligibility Criteria

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

Inclusion Criteria:

  • Patients referred for conventional CRT
  • Severe heart failure (LVEF, a measure of heart pumping, < 35% - severe)
  • Prolonged QRS duration (>120ms)
  • Adults willing to take part (age > 18 years)
  • Able to give consent

Exclusion Criteria:

  • Unable to give consent
  • Children (age < 18 years)
  • Pregnant women

Sites / Locations

  • Hammersmith Hospital Imperial College NHS trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart failure and abnormal cardiac conduction

Arm Description

Subjects will have an attempt at His-bundle pacing, left bundle pacing and biventricular pacing. Pacing at the His bundle and the left bundle will be attempted using a Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Biventricular pacing will utilise a left ventricular lead placed in the coronary sinus using any of the 5 manufactures of CS leads Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical or in participants receiving permanent conduction system pacing left ventricular pacing will be achieved using a Cordis ATW™ wire placed in the coronary sinus.

Outcomes

Primary Outcome Measures

Acute change is systolic blood pressure
Mean change in systolic blood pressure (mmHg) from atrial pacing to AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in mmHg.
Acute electrical measurements
Mean change in left ventricular activation time (Milliseconds) (measured using ECGI) during AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in Milliseconds.

Secondary Outcome Measures

Conduction system battery longevity
The measurements include battery longevity measured in months.
Conduction system lead threshold
The measurements include lead threshold to achieved QRS narrowing measured in Volts at 0.5ms and 1ms.
Heart failure symptoms
Heart failure symptoms of patients with permanent conduction system leads will be assessed at follow up at 3 month, 6 months and 12 months. The symptoms will be assessed using the Minnesota living with heart failure questionnaire score.
Left ventricular ejection fraction
Patients with permanent conduction system leads will undergo a repeat echocardiography and measure their left ventricular ejection fraction.
Cardiopulmonary exercise testing
Patients with permanent conduction system leads will undergo symptom assessment with a repeat cardio-pulmonary exercise test to measure MVO2 in litres/minute.

Full Information

First Posted
November 4, 2019
Last Updated
March 21, 2023
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT04221763
Brief Title
Mechanisms and Innovations in Cardiac Resynchronisation Therapy
Acronym
MIC
Official Title
Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.These modalities include biventricular pacing and conduction system pacing utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological form of pacing. The study hypothesises that this will produce more effective cardiac resynchronisation.
Detailed Description
This is a single centre acute electrical/haemodynamic and observational study of a subgroup of patients with heart failure. A total of 60 will be recruited. The acute study involves within patient comparison of biventricular and conduction system pacing using detailed electrical mapping and high precision haemodynamic measurement protocol. Participants will have permanent conduction system pacing if; Baseline left bundle branch block and QRS > 140ms or QRS >150ms and any QRS morphology AND Conduction system pacing is successful at reducing QRS duration by 20ms or more with satisfactory pacing parameters. Participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3 months, 6 months and 12 months. Non-invasive markers including mechanical activation pattern (echocardiography and cardiac MRI) and electrical activation pattern (ultra-high frequency electrocardiography) will be used to identify the characteristics of patients who benefit from conduction system pacing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Ventricular Systolic Dysfunction, Left Bundle-Branch Block, Right Bundle-Branch Block, Non-Specific Intraventricular Conduction Defect
Keywords
Cardiac resynchronization therapy, His bundle pacing, Haemodynamics, ECGI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
60 patients with heart failure, severe left ventricular systolic dysfunction and cardiac conduction abnormality (QRS > 120ms) will be recruited and undergo an attempt at His bundle, left bundle pacing and biventricular pacing. Patients will have acute haemodynamic and electrical measurements.
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart failure and abnormal cardiac conduction
Arm Type
Experimental
Arm Description
Subjects will have an attempt at His-bundle pacing, left bundle pacing and biventricular pacing. Pacing at the His bundle and the left bundle will be attempted using a Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Biventricular pacing will utilise a left ventricular lead placed in the coronary sinus using any of the 5 manufactures of CS leads Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical or in participants receiving permanent conduction system pacing left ventricular pacing will be achieved using a Cordis ATW™ wire placed in the coronary sinus.
Intervention Type
Device
Intervention Name(s)
His-bundle pacing.
Other Intervention Name(s)
Left bundle pacing, Biventricular pacing, Combined His-bundle and left ventricular epicardial pacing (HOT-CRT)
Intervention Description
Cardiac resynchronisation therapy can be achieved using biventricular pacing involving placement of three leads into the right atrium, right ventricle and coronary sinus (epicardial left ventricle). Alternatively the third lead may be placed at the bundle of His or left ventricular septum to pace the left bundle directly.
Primary Outcome Measure Information:
Title
Acute change is systolic blood pressure
Description
Mean change in systolic blood pressure (mmHg) from atrial pacing to AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in mmHg.
Time Frame
20 minutes
Title
Acute electrical measurements
Description
Mean change in left ventricular activation time (Milliseconds) (measured using ECGI) during AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in Milliseconds.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Conduction system battery longevity
Description
The measurements include battery longevity measured in months.
Time Frame
6 weeks, 3 months, 6 months, 12 months.
Title
Conduction system lead threshold
Description
The measurements include lead threshold to achieved QRS narrowing measured in Volts at 0.5ms and 1ms.
Time Frame
6 weeks, 3 months, 6 months, 12 months.
Title
Heart failure symptoms
Description
Heart failure symptoms of patients with permanent conduction system leads will be assessed at follow up at 3 month, 6 months and 12 months. The symptoms will be assessed using the Minnesota living with heart failure questionnaire score.
Time Frame
6 months
Title
Left ventricular ejection fraction
Description
Patients with permanent conduction system leads will undergo a repeat echocardiography and measure their left ventricular ejection fraction.
Time Frame
12 months
Title
Cardiopulmonary exercise testing
Description
Patients with permanent conduction system leads will undergo symptom assessment with a repeat cardio-pulmonary exercise test to measure MVO2 in litres/minute.
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: Patients referred for conventional CRT Severe heart failure (LVEF, a measure of heart pumping, < 35% - severe) Prolonged QRS duration (>120ms) Adults willing to take part (age > 18 years) Able to give consent Exclusion Criteria: Unable to give consent Children (age < 18 years) Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Whinnett, BM BS B
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Hammersmith Hospital Imperial College NHS trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share the electrical data obtained from non-invasive electrical mapping with Medtronic (industry company)
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
Medtronic will only have access to anonymised data in the form of non-invasive electrical maps (ECGi, CardioInsight)
Citations:
PubMed Identifier
23900696
Citation
Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.
Results Reference
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PubMed Identifier
30681348
Citation
Vijayaraman P, Herweg B, Ellenbogen KA, Gajek J. His-Optimized Cardiac Resynchronization Therapy to Maximize Electrical Resynchronization: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006934. doi: 10.1161/CIRCEP.118.006934.
Results Reference
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Mechanisms and Innovations in Cardiac Resynchronisation Therapy

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