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Heart FailureNCT03495505

CT Guided WiSE-CRT

A study testing WiSE-CRT in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
WiSE-CRT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited Kingdom
Study dates
31 Aug 2018to 5 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Contraindication to anticoagulation therapy
  • Insufficient acoustic window to the LV as assessed from diagnostic transthoracic echocardiography
  • Left atrial or ventricular thrombus

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Guys and St Thomas' NHS Foundation Trust

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
WiSE-CRT
Keywords
WiSE-CRT, Endocardial Pacing Optimisation, Cardiac Resynchronisation Therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WiSE-CRTDevice

    Also called Cardiac Resynchronisation Therapy, Wireless Endocardial Pacing, WICS device

    Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.

Study groups in NCT03495505
Study groupRoleWhat they receive
WiSE-CRT eligibleExperimentalPatients 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.
Receives: Device: WiSE-CRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in acute haemodynamic response (dp/dt) during the procedure

    Measured: Baseline and during procedure

Secondary outcomes (4)
  1. Change in Minnesota Living with Heart Failure Questionnaire Score

    This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.

    Measured: Baseline and 6 months

  2. Evidence of reverse remodelling (≥15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation

    Measured: Baseline and 6 months

  3. Change in 6 minute walk test

    Measured: Baseline and 6 months

  4. Change in cardio-pulmonary exercise test score

    This measures a change in the patients symptoms from baseline to 6-months post intervention. A higher value represents a better outcome.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start31 Aug 2018
  3. Primary completion5 May 2021
  4. Study completion5 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
20 patients will be recruited into this feasibility study with a 6 month follow-up. There will be no blinding nor randomisation.
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495505
Sponsor's protocol ID
239322
Status last verified
Mar 2022
First submitted
26 Mar 2018
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PubMed 27206819
  • Reddy VY, Miller MA, Neuzil P, Sogaard P, Butter C, Seifert M, Delnoy PP, van Erven L, Schalji M, Boersma LVA, Riahi S. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129. doi: 10.1016/j.jacc.2017.02.059.

    PubMed 28449772
  • Ypenburg C, van Bommel RJ, Delgado V, Mollema SA, Bleeker GB, Boersma E, Schalij MJ, Bax JJ. Optimal left ventricular lead position predicts reverse remodeling and survival after cardiac resynchronization therapy. J Am Coll Cardiol. 2008 Oct 21;52(17):1402-9. doi: 10.1016/j.jacc.2008.06.046.

    PubMed 18940531
  • Miller MA, Neuzil P, Dukkipati SR, Reddy VY. Leadless Cardiac Pacemakers: Back to the Future. J Am Coll Cardiol. 2015 Sep 8;66(10):1179-89. doi: 10.1016/j.jacc.2015.06.1081.

    PubMed 26337997

Questions about this trial

What is this clinical trial studying?

A study testing WiSE-CRT in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in acute haemodynamic response (dp/dt) during the procedure (time frame: Baseline and during procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495505, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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