CT Guided WiSE-CRT

March 28, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust

Image Optimisation and Guidance for Wireless Endocardial Cardiac Resynchronisation Therapy: The CT Guided Trial

This feasibility study will use CT scanning to identify the optimal location for placement of the WiSE-CRT system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is estimated to affect at least 10% of adults aged over 70 years old, with a 12-month all-cause mortality rate of 7% in stable patients. Cardiac resynchronisation therapy (CRT) is an important intervention for patients with severe left ventricular (LV) systolic impairment and helps to improve well-being and reduce morbidity and mortality. CRT is achieved by placing endocardial pacing leads into the right atrium and right ventricle and then placing a third pacing lead through the coronary sinus (CS) to enable epicardial LV pacing, thus achieving ventricular resynchronisation. Although this is a successful therapy, overall 30-40% of patients will fail to respond. Additionally, even in those eligible for CRT, approximately 8-10% of patients cannot have it implanted due to anatomical abnormalities such as venous occlusion, inappropriate CS targets, diffuse scar resulting in inappropriately high pacing thresholds or phrenic nerve stimulation. In these circumstances other avenues to achieve biventricular pacing needs to be sought.

The wireless CRT system (WiSE-CRT, EBR Systems) has been developed to overcome these issues. It uses an endocardial LV electrode to achieve biventricular pacing negating the need to implant a pacing lead through the CS. There are several advantages of endocardial LV pacing such as a greater selection of pacing sites, possibility of lower pacing outputs compared with conventional leads in the CS and it appears to be a more physiological way to pace. The WiSE-CRT system is used in conjunction with a single or dual-chamber pacemaker and is made up of several components. A transmitter is implanted subcutaneously, attached to a battery. This detects right ventricular pacing from the co-implant and then delivers ultrasonic energy which is received by an electrode placed in the LV endocardium to enable biventricular pacing. The transmitter must be placed in a position with an adequate "acoustic window," which requires a line from the transmitter to the LV that is free of significant tissue or bone. Additionally, the endocardial electrode must be placed in close proximity to the transmitter. In a study of 35 patients, the WiSE-CRT system was successful implanted in 97.1% of cases, with 97% achieving biventricular pacing at 1 month and 84.8% showing an improvement in the clinical composite score at 6 months. These results are particularly encouraging given the device was used in patients who had failed conventional CRT, representing a difficult patient group.

The major advantage of the WiSE-CRT system is that the LV electrode can be placed anywhere within the ventricle. Studies have shown that patient outcomes are improved by pacing at a site which avoids ventricular scar and targets an area of latest mechanical activation. These sites will vary according to the aetiology underlying HF. In addition, using conventional fluoroscopy to guide pacing lead implants has been shown to be inaccurate when compared with computed tomography (CT). Our group have previously shown that magnetic resonance imaging (MRI) can be overlaid on fluoroscopic images to help guide epicardial pacing to a specific location and improve outcomes. Many patients undergoing a WiSE-CRT implant will be unable to have a MRI due to their previous pacemaker implant. However, guidance may still be achieved using CT scanning.

The proximity and orientation of the transmitter to the endocardial electrode is important in determining the battery life of the WiSE-CRT system. Yeh et al. showed that a large proportion of patients have at least two suitable acoustic windows for placement of the transmitter. This provides the operator with more opportunities to carefully select an ideal location. However, once implanted the endocardial electrode must be placed within the acoustic window which limits the number of sites the electrode can then be placed.

Identifying the best location for both the transmitter and endocardial electrode is essential to target the most viable myocardium and improve patient outcomes. Ideally this should be achieved before the patient has undergone any procedure since implanting the transmitter limits the potential locations for the electrode. We believe CT guidance can provide satisfactory information to optimise the location for both the transmitter and electrode which will increase the patient response rate and improve outcomes.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Guys and St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18
  • Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
  • Patients with pre-existing permanent pacing systems in situ.
  • Left ventricular systolic impairment with ejection fraction of <45%
  • Clinical symptoms of heart failure despite optimal medical therapy (NYHA II- IV)
  • QRS duration >120ms on surface ECG

Exclusion Criteria:

  • Creatinine clearance <30mls/minute (GFR)
  • Severe allergy to contrast medium or severe asthma/ COPD
  • Life expectancy <1 year
  • Significant aortic valve disease or prosthesis
  • Significant mitral regurgitation
  • Significant peripheral vascular disease
  • Contraindication to anticoagulation therapy
  • Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography
  • Left atrial or ventricular thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WiSE-CRT eligible
Patients need to meet all the inclusion and none of the exclusion criteria in order to be eligible for the study. All these patients will receive the WiSE-CRT implant.
Device: WiSE-CRT
Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.
Other Names:
  • Cardiac Resynchronisation Therapy
  • Wireless Endocardial Pacing
  • WICS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in acute haemodynamic response (dp/dt) during the procedure
Time Frame: Baseline and during procedure
Baseline and during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Minnesota Living with Heart Failure Questionnaire Score
Time Frame: Baseline and 6 months
This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.
Baseline and 6 months
Evidence of reverse remodelling (≥15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation
Time Frame: Baseline and 6 months
Baseline and 6 months
Change in 6 minute walk test
Time Frame: Baseline and 6 months
Baseline and 6 months
Change in cardio-pulmonary exercise test score
Time Frame: Baseline and 6 months
This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Steven Niederer, DPhil, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Actual)

May 5, 2021

Study Completion (Actual)

May 5, 2021

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 239322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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