Condition category
Circulatory System
Date applied
05/03/2015
Date assigned
18/03/2015
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/08/2014

Overall trial end date

28/12/2015

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial participating centre

CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
6720 Bertner Ave
Houston
TX 77030
United States of America

Trial participating centre

Drexel University College of Medicine
Philadelphia
-
United States of America

Trial 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

Trial participating centre

London Health Sciences Centre - University Campus
London
London
-
Canada

Trial participating centre

Lourdes Cardiology Services
63 Kresson Rd Cherry Hill
New Jersey
08034
United States of America

Trial participating centre

Northwestern University
633 Clark Street Evanston
Illinois
60208
United States of America

Trial participating centre

Royal Columbian Hospital
330 E Columbia Street
New Westminster
BC V3L 3W7
Canada

Trial participating centre

Sequoia Hospital
170 Alameda de las Pulgas Redwood City
California
94062
United States of America

Trial participating centre

University of Calgary
2500 University Dr NW
Calgary
T2N 1N4
Canada

Trial participating centre

University of Minnesota Medical Center Fairview
2450 Riverside Ave Minneapolis
Minnesota
55454
United States of America

Trial 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

http://www.medtronic.com/

Funders

Funder type

Industry

Funder name

Medtronic

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/10/2015: the Netherlands was removed from the countries of recruitment.