Plain English Summary
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
Study website
Contact information
Type
Public
Contact name
Mr Michael Bennett
ORCID ID
Contact details
8200 Coral Sea Street NE
Mounds View
55112
United States of America
+1 (0)763 514 4000
space@medtronic.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G140211
Study information
Scientific title
Feasibility of extravascular pacing from a novel lead location, an acute clinical evaluation
Acronym
SPACE
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Overall study end date
28/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
50
Participant 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.)
Recruitment start date
28/02/2015
Recruitment end date
09/10/2015
Locations
Countries of recruitment
Canada, United States of America
Study participating centre
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
6720 Bertner Ave
Houston
TX 77030
United States of America
Study participating centre
Drexel University College of Medicine
Philadelphia
-
United States of America
Study participating centre
University Institute of Cardiology and Pneumology Quebec (Institute Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ))
2725, chemin Sainte-Foy
Québec
G1V 4G5
Canada
Study participating centre
London Health Sciences Centre - University Campus
London
London
-
Canada
Study participating centre
Lourdes Cardiology Services
63 Kresson Rd
Cherry Hill
New Jersey
08034
United States of America
Study participating centre
Northwestern University
633 Clark Street
Evanston
Illinois
60208
United States of America
Study participating centre
Royal Columbian Hospital
330 E Columbia Street
New Westminster
BC V3L 3W7
Canada
Study participating centre
Sequoia Hospital
170 Alameda de las Pulgas
Redwood City
California
94062
United States of America
Study participating centre
University of Calgary
2500 University Dr NW
Calgary
T2N 1N4
Canada
Study participating centre
University of Minnesota Medical Center Fairview
2450 Riverside Ave
Minneapolis
Minnesota
55454
United States of America
Study participating centre
University of Washington Medical Center
1959 NE Pacific Street
Seattle
98195
United States of America
Sponsor information
Organisation
Medtronic (USA)
Sponsor details
710 Medtronic Parkway
Minneapolis
55432
United States of America
+1 (0)763 514 4000
space@medtronic.com
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Medtronic
Alternative name(s)
Medtronic Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|