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.
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
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 group | Role | What they receive |
|---|---|---|
| WiSE-CRT eligible | Experimental | 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. Receives: Device: WiSE-CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute haemodynamic response (dp/dt) during the procedure
Measured: Baseline and during procedure
Secondary outcomes (4)
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
Evidence of reverse remodelling (≥15% improvement in end systolic volume) on transthoracic echocardiogram at 6 months post CRT implantation
Measured: Baseline and 6 months
Change in 6 minute walk test
Measured: Baseline and 6 months
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.
- First posted12 Apr 2018
- Study start31 Aug 2018
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Steven Niederer, DPhil, Principal investigator, King's College London
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 27206819Reddy 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 28449772Ypenburg 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 18940531Miller 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Optimisation and Guidance for Wireless Endocardial Cardiac Resynchronisation Therapy: The CT Guided Trial
- ClinicalTrials.gov ID
- NCT03495505
- Acronym / sponsor ID
- 239322
- Conditions
- Heart Failure
- Keywords
- WiSE-CRT, Endocardial Pacing Optimisation, Cardiac Resynchronisation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will use CT scanning to identify the optimal location for placement of the WiSE-CRT system.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 patients will be recruited into this feasibility study with a 6 month follow-up. There will be no blinding nor randomisation.
| Arm | Type | Receives |
|---|---|---|
| WiSE-CRT eligible | Experimental | Device: WiSE-CRTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WiSE-CRTAlso: Cardiac Resynchronisation Therapy, Wireless Endocardial Pacing, WICS deviceIntervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode. | Device | WiSE-CRT eligible |
Primary outcome
Change in acute haemodynamic response (dp/dt) during the procedure
Time frame: Baseline and during procedure
4 secondary outcomes
Change in Minnesota Living with Heart Failure Questionnaire Score
Time frame: 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
Change in 6 minute walk test
Time frame: Baseline and 6 months
Change in cardio-pulmonary exercise test score
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 27206819Ponikowski 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.
- Background: PubMed 28449772Reddy 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.
- Background: PubMed 18940531Ypenburg 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.
- Background: PubMed 26337997Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Niederer, DPhil principal investigator
King's College London
1 site in 1 country: see every site and its status.
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.