Study utilizing a novel mapping catheter in heart arrhythmias
| ISRCTN | ISRCTN93591221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93591221 |
| Secondary identifying numbers | BWI_2017_05 |
- Submission date
- 17/07/2018
- Registration date
- 02/08/2018
- Last edited
- 13/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims:
Study catheters are used to understand and record electrical impulses in various places in a person's heart, which can be used to help doctors find places in hearts that may need to be treated. Catheters also help doctors to visualise important locations in a person's heart. Therefore, catheters are used for diagnosis, rather than delivering therapy.
The purpose of this study is to look at the safety and design of a new type of catheter used to support procedures to treat cardiac arrhythmias (irregular heartbeat). This new cathether is designed to provide higher quality signals from the heart compared to other diagnostic catheters.
Who can participate?
Patients diagnosed with and who are eligible for ablation procedures for ventricular tachycardia, atrial tachycardia, or atrial fibrillation.
What does the study involve?
The new mapping catheter will be used to help a patient’s doctor understand the electrical activity in the patient’s heart before, during, and after a standard ablation procedure for a study patient’s cardiac arrhythmia. This catheter does not deliver any therapy to the patient. The intent of this study is to confirm the study catheter can perform as it is has been designed. It will be used in place of the standard catheter that would have otherwise been used in the procedure. The delivery of therapy to treat the cardiac arrhythmia following use of the new catheter will be according to the doctor’s normal practice (the “standard of care”) using a commercially available therapeutic catheter, but the use of the diagnostic mapping catheter is not expected to impose any additional direct safety risks. A standard radiofrequency ablation procedure may pose complications such as pericardial or pleural effusion (accumulation of excess fluid around the heart or lungs), pericarditis (inflammation of the external layer of the heart, 0% to 50%), pericarditis (inflammation of the external layer of the heart, 0% to 50%), phrenic nerve injury (injury of the nerve that originates in the neck and passes down between the lungs and heart to reach the diaphragm, risk 0 to 0.4%), and other complications. Patients interested in participating in this study should discuss these risks with a study doctor.
What are the possible benefits and risks of participating?
There are no known benefits to participants taking part in this study; however, the new catheter may allow the doctor to better identify problematic electrical activity in the heart of patients. The possible risks to participants taking part are the standard risks of a radiofrequency ablation procedure, therefore, the use of the diagnostic mapping catheter is not expected to impose any additional direct safety risks. A standard radiofrequency ablation procedure may pose complications such as pericardial or pleural effusion (accumulation of excess fluid around the heart or lungs), pericarditis (inflammation of the external layer of the heart, 0% to 50%), pericarditis (inflammation of the external layer of the heart, 0% to 50%), phrenic nerve injury (injury of the nerve that originates in the neck and passes down between the lungs and heart to reach the diaphragm, risk 0 to 0.4%), and other complications. Patients interested in participating in this study should discuss these risks with a study doctor.
Where is the study run from?
1. UZ Anterwerpen, Antwerp, Belgium
2. OLV Ziekenhuis, Aalst, Belgium
3. Virga Jessa Ziekenhuis, Hasselt, Belgium
4. St. Bart’s Hospital, London, UK
5. Royal Brompton Hospital, London, UK
When is study starting and how long is it expected to run for?
The start date of the trial is July 2018. The study duration is expected to be approximately 7 months, which includes the enrollment phase.
Who is funding the study?
Biosense Webster, Inc (USA)
Who is the main contact?
Nathalie Macours
nmacours@its.jnj.com
Contact information
Public
Leonardo Da Vincilaan 15
Diegem
1831
Belgium
Study information
| Study design | Interventional prospective multi-center single-arm non-randomised open-label early feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Prospective early feasibility study utilizing a novel mapping catheter for mapping in the atria and ventricles |
| Study objectives | Assess the feasibility and safety of the use of a novel mapping catheter for mapping in the atria and ventricles |
| Ethics approval(s) | 1. Belgium: Universiteit Anterwepen Ethisch Comite, UZA, Wilrijkstraat 10, 2650 Edegem, Belgium, 09/07/2018, REC ref: 18/18/227 2. UK: West of Scotland REC 4, Research Ethics, Clinical Research and Development, West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, G3 8SJ, UK, 11/10/2018, REC ref: 18/WS/0165 |
| Health condition(s) or problem(s) studied | Ventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation |
| Intervention | The novel diagnostic mapping catheter will be used by doctors to better understand areas of the heart that initiate or sustain irregular heart rhythms (“cardiac arrhythmias”). The patient will have this novel catheter used in place of an institution’s standard diagnostic mapping catheter during the study procedure (i.e. in place of what would have been used had the study patient not chosen to participate in the study but still have a procedure for their cardiac arrhythmia). Diagnostic catheters do not delivery therapy and aid doctors in identifying areas that may need therapy and help doctors confirm the treatment has been delivered. At the beginning of the procedure, the doctor will create a three-dimensional map of a patient’s heart and gather information from areas of potential irregular electrical activity using the study catheter with the Biosense Webster CARTO® 3 System. After collecting this information, the doctor will provide the standard treatment of the patient’s cardiac arrhythmia (i.e. what would normally be provided had the study patient not participated in the study). During and after the standard procedure for the study patient’s arrhythmia, the doctor is asked to continue to use the novel diagnostic mapping catheter for any other activities. Enrolled study patients will be discharged per the hospital’s standard of care following these types of procedures. Study patients will have either a phone call or in-clinic check-up at 7 to 9 days later. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Completion of pre-ablation mapping and clinically indicated mapping with the novel mapping catheter without resort to using a nonstudy mapping catheter, assessed during the patient's procedure. 2. Incidence of serious adverse events, self-reported by patients and assessed from the time of enrolment through to the 7 day follow-up visit. |
| Secondary outcome measures | Deployment, use, and mapping of the novel mapping catheter in the atria and ventricles during the study procedure, characterised with descriptive statistics. |
| Overall study start date | 01/10/2017 |
| Completion date | 08/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Diagnosed with and is a candidate for clinically‐indicated catheter ablation procedure for the management of: 1.1. Ischemic ventricular tachycardia 1.2. Atrial tachycardia/atypical atrial flutter/paroxysmal atrial fibrillation following a pulmonary vein isolation ablation or mitral valve repair procedure 1.3. Persistent atrial fibrillation 2. Aged 18 years or older 3. Able to provide informed consent 4. Able and willing to comply with all pre‐, post‐, and follow‐up testing and requirements |
| Key exclusion criteria | 1. History of continuous atrial fibrillation (AF) sustained longer than 12 months 2. History of AF <7 days and no previous AF ablation procedure 3. Previously diagnosed with long‐standing persistent atrial fibrillation 4. Previously diagnosed with idiopathic PVC/VT 5. Study arrhythmia secondary to reversible cause 6. Atrial arrhythmias: patients with a left atrial size >55 mm 7. LVEF ≤ 25% for VT patients 8. LVEF ≤ 40% for AF patients 9. Documented thrombus in the chamber to be mapped by the study catheter on imaging 10. Contraindication to anticoagulation (i.e. heparin, warfarin, dabigatran) 11. History of blood clotting or bleeding abnormalities (e.g. hypercoagulable state) 12. Myocardial infarction within the past 2 months (60 days) 13. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 14. Uncontrolled heart failure or NYHA function class III or IV 15. Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 3 months (90 days) 16. Implanted with a prosthetic valve 17. Active systemic infection 18. Diagnosed atrial or ventricular myxoma 19. Implanted with an interatrial baffle or patch 20. Atrial septal closure within the past 6 weeks (42 days) 21. Presence of a condition that precludes vascular access 22. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation 23. Women who are pregnant (as evidenced by pregnancy test if pre‐menopausal) 24. Enrollment in an investigational study evaluating another device or drug |
| Date of first enrolment | 03/08/2018 |
| Date of final enrolment | 20/12/2018 |
Locations
Countries of recruitment
- Belgium
- England
- United Kingdom
Study participating centres
Belgium
Belgium
Belgium
United Kingdom
United Kingdom
Sponsor information
Industry
33 Technology Drive
Irvine
92807
United States of America
| Website | http://biosensewebster.com |
|---|---|
"ROR" |
https://ror.org/04yzcpd71 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 08/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Datasets generated during and/or analysed during the current study may be available upon request from Richard Schilling, MD (Richard.Schilling@bartshealth.nhs.uk). Study patient identity and participation in the study will be treated strictly confidential and patients will not be identified by name or in any other identifying manner in files, results, or publications concerning this study. Study patient Information will be encoded in order to safeguard confidentiality and if the results of the scientific and clinical researches are published, used in reports of the study, or for scientific presentations, identities will remain confidential. The sponsor will take all necessary steps to protect privacy and will review all requests for data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/03/2019: The following changes were made to the trial record:
1. Ethics approval details updated.
2. The overall trial end date was changed from 30/12/2018 to 08/02/2019.
3. The intention to publish date was changed from 30/12/2018 to 08/02/2020.
4. Colombia was removed from the countries of recruitment.
03/08/2018: The recruitment start date was changed from 02/07/2018 to 03/08/2018.
