Extravascular pacing acute clinical evaluation
| ISRCTN | ISRCTN79250975 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79250975 |
| Secondary identifying numbers | G140211 |
- Submission date
- 05/03/2015
- Registration date
- 18/03/2015
- Last edited
- 13/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The purpose of this study is to see if it is possible to pace the heart using a market released EP catheter (plastic tube) as part of a research system. The results of the study will provide data to support Medtronic in the research and development of a potential extravascular Implantable Cardioverter-Defibrillator (ICD) system. A ICD is a tiny, battery run computer that is implanted just under the skin on the chest. It is designed to treat heart palpitations (heart beating rapidly and irregularly).This system uses a catheter temporarily inserted into the body to read the electrical activity of the heart (sensing) and send electrical signals to the heart to modify its rhythm (pacing). In this study, pacing will be used to attempt to speed up the heart rate a little.
Who can participate?
Adults (over 18) undergoing one of the following surgical procedures: cardiothoracic surgery, VT ablation or subcutaneous ICD implant.
What does the study involve?
This trial is testing the feasibility of pacing the heart with a research system. The results of the study will provide data to support Medtronic in the research and development of a potential extravascular Implantable Cardioverter-Defibrillator (ICD) system. Each participant has the procedure before they undergoe their planned surgery and it takes about 20 minutes from the first incision until the point where all the research components are removed. Pacing, sensing, and extracardiac muscle stimulation is collected during this time. Participants are followed through their routine post-surgery follow-up visit to ensure that the catheter tunneling track used for the pacing is appropriately recovering, and to collect data on new or updated adverse events, device deficiencies, study deviations, study exit, and death. This visit occurs between 7 and 50 days after the procedure.
What are the possible benefits and risks of participating?
There is no direct benefit to subjects participating in this study. Potential risks and discomforts associated with participating in this study include, but are not limited to, inappropriate modification of the heart rhythm, arrhythmia (irregular heart beat), electronic shock, palpitations, stimulation of the body other than the heart and muscle pain. Risks of the surgery include damage to the heart muscle, tissues, veins, arteries, diaphragm or lungs, blood or air embolism, bleeding, or bruising, pneumothorax (blood in the lungs), or arrhythmia. Participants may also be at an increased risk of infection, stroke, and a skin irritation or allergy to the adhesive on the ECG electrode patch that is used. Some of the risks mentioned may lead to death.
Where is the study run from?
This is an international study taking place in 13 hospitals in Canada, The Netherlands and the USA.
When is the study starting and how long is it expected to run for?
August 2014 to December 2015
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Mr Michael Bennett
space@medtronic.com
Contact information
Public
8200 Coral Sea Street NE
Mounds View
55112
United States of America
| Phone | +1 (0)763 514 4000 |
|---|---|
| space@medtronic.com |
Study information
| Study design | Prospective global multi-center non-randomized acute feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility of extravascular pacing from a novel lead location, an acute clinical evaluation |
| Study acronym | SPACE |
| Study objectives | This study uses a market-released diagnostic catheter placed in the proposed novel lead location to assess the feasibility of pacing the heart from this location, collect sensing data, and observe the degree of non-cardiac muscle stimulation. This feasibility study is not powered to formally test a hypothesis. |
| Ethics approval(s) | 1. US FDA IDE, 15/01/2015, ref: G140211 2. Health Canada ITA, 29/01/2015, ref: 233524 |
| Health condition(s) or problem(s) studied | This is an acute data collection study for pacing feasibility |
| Intervention | This trial will be testing the feasibility of pacing the heart with a research system. The results of the study will provide data to support Medtronic in the research and development of a potential extravascular Implantable Cardioverter-Defibrillator (ICD) system. The procedure will precede the subject’s planned surgical procedure and is expected to take approximately 20 minutes from first incision till the point where all research components are removed from the patient. Pacing, sensing, and extracardiac muscle stimulation will be collected during this visit. Subjects will be followed through their routine post-surgery follow-up visit to ensure that the catheter tunneling track used for the pacing is appropriately recovering, and to collect data on new or updated adverse events, device deficiencies, study deviations, study exit, and death. The time required to assess for potential adverse events at this visit is expected to be approximately 5 minutes. This visit must occur between 7 and 50 days post-procedure. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Primary Objective: Pacing Efficacy 1. Endpoint Definition Subjects will demonstrate a successful pacing outcome if heart capture is observed for at least 3 consecutive beats after pacing stimuli are delivered into at least one out of all tested pacing vectors using pacing current ≤ 20 mA and pacing PW ≤ 10 ms. 2. Analysis Methods The proportion of subjects who have successful pacing outcome will be calculated along with the lower bound of the one-sided 95% confidence interval. The exact method will be used to calculate the lower 95% confidence bound. 3. Determination of Subjects for Analysis All subjects who complete pacing testing according to the CIP will be included in the analysis. |
| Secondary outcome measures | 1. Collection of Sensing Data R-wave amplitude will be summarized using mean and standard deviation for each ECG vector collected via EP recording system for future sensing algorithm development 2. Determine the Degree of Muscle Stimulation During Pacing The degree of muscle stimulation (e.g., high, low, none) will be visually assessed and summarized for each pacing vector collected to provide information about non-cardiac muscle stimulation when pacing |
| Overall study start date | 01/08/2014 |
| Completion date | 28/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Subject must be: 1. Undergoing surgical procedure for approved indications for cardiothoracic surgery where a midline sternotomy is planned or 2. VT ablation procedure with epicardial access indicated, or 3. Implant of a subcutaneous ICD 4. Subject must be willing to provide informed consent 5. Subject must be > 18 years old |
| Key exclusion criteria | 1. Subject is considered to be at high risk for infection, 2. Subject has NYHA Class IV, 3. Subject has subcutaneous ICD (S-ICD®) implanted, 4. Subject has an implanted active cardiac or non-cardiac device (e.g., ICD, Pacemaker, Neuro stimulator) that is enabled and can produce electrical stimuli during study procedure 5. Subject at high risk of stroke, Subject is pacemaker dependent 6. Subject had previous pericarditis or prior sternotomy 7. Subject has hiatus hernia or moderate or worse pectus excavatum 8. Subject has significant RV dilation caused by pulmonary hypertension or tricuspid disease 9. Subject has had myocardial infarction within the last 3 months 10. Subject has unstable angina 11. Subject has known skin irritations to the Physio Control Fast-Patch® ECG Electrode 12. Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from a Medtronic study manager 13. Subject has medical conditions that would limit study participation 14. Subject is pregnant 15. Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.) |
| Date of first enrolment | 28/02/2015 |
| Date of final enrolment | 09/10/2015 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centres
Houston
TX 77030
United States of America
-
United States of America
Québec
G1V 4G5
Canada
London
-
Canada
Cherry Hill
New Jersey
08034
United States of America
Evanston
Illinois
60208
United States of America
New Westminster
BC V3L 3W7
Canada
Redwood City
California
94062
United States of America
Calgary
T2N 1N4
Canada
Minneapolis
Minnesota
55454
United States of America
Seattle
98195
United States of America
Sponsor information
Industry
710 Medtronic Parkway
Minneapolis
55432
United States of America
| Phone | +1 (0)763 514 4000 |
|---|---|
| space@medtronic.com | |
| Website | http://www.medtronic.com/ |
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Editorial Notes
22/10/2015: the Netherlands was removed from the countries of recruitment.
