Extravascular pacing acute clinical evaluation

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN79250975
• Date of registration: 18/03/2015
• Prospective Registration: No
• Primary sponsor: Medtronic (USA)
• Public title: Extravascular pacing acute clinical evaluation
• Scientific title: Feasibility of extravascular pacing from a novel lead location, an acute clinical evaluation
• Date of first enrolment: 28/02/2015
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN79250975
• Study type: Interventional
• Study design: Prospective global multi-center non-randomized acute feasibility study (Treatment)

Countries of recruitment

Canada, United States of America

Contacts

• Name: Michael Bennett

Key inclusion & exclusion criteria

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
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.)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

This is an acute data collection study for pacing feasibility
Circulatory System

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

G140211

Source(s) of Monetary Support

Medtronic