SPIKE FLOW Endocardial Lead Safety and Performance Study

SPIKE FLOW temporary leads are intended for temporary intravenous cardiac pacing and recording of intravenous cardiac electrical signals. The products are designed to be used for a continuous period of not more than 7 days. The indications for temporary pacing typically are the following:

• Acute myocardial infarction;
• Asystole;
• Bradycardia;
• AV block;
• Ventricular tachyarrhythmias;
• Overdrive suppression of tachyarrhythmias;
• High frequency pacing during percutaneous procedures;
• Cardiac surgery requiring backup pacing, surveillance of cardiac activity. The leads may be introduced, connected, and put into operation only by experienced and trained medical staff in heart pacing and percutaneous access.

The physicians entitled to place a temporary pacemaker should be familiar with the insertion equipment (puncture needle and sheath), electro-catheters and connectors, and the external pulse generator available in their own hospital settings.

Endocardial SPIKE FLOW family leads are single-use sterile devices, class III according to MDR (EU) 2017/745, used for temporary cardiac pacing, for short-term therapy of diseases which require the stimulation of the heart by means of electrical energy supplied by external pulse generators.

The rationale of the study is to evaluate, through clinical investigation according to its intended conditions of use, the effectiveness of SPIKE FLOW device's performance and to confirm the safety of the medical device.

Specifically, to assess safety and effectiveness of the SPIKE FLOW when using the balloon to facilitate lead insertion. Furthermore, we want to identify any risks (previously known or previously unidentified) associated with adverse events and/or complications that could occur during use in order to confirm or, if necessary, revise the assessments made during the risk management process.

The sample size requirement for this study is 131 adult subjects that can be enrolled in 3 different investigational sites in Italy. To ensure balanced enrollment and shorten the study's timeframe, each center will be required to enroll a minimum of 30 patients, while the remaining sample will be competitively recruited among centers until a total of 131 patients is reached. The enrollment is anticipated to take approximately 1 year.

Potential subjects must meet ALL of the following criteria to be eligible for enrollment into the study:

1. Subject undergoing a surgical or an interventional procedure, requiring temporary cardiac pacing per investigator's medical judgment or subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent;
2. Subject is at least 18 years of age;
3. Subject provides written informed consent to the study.

Potential subjects will be excluded if ANY of the following criteria apply:

1. Subject has a co-existing temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator;
2. Subject in cardiogenic shock;
3. Subject is pregnant or breastfeeding;
4. Subject had a stroke within 6 months prior to enrollment;
5. Subject has renal insufficiency with creatinine >2 mg/dl;
6. Subject with known bleeding diathesis;
7. Subject with a history of deep vein thrombosis or pulmonary embolization within 6 months;
8. Subject with known tricuspid valve disease that may impede catheter advancement to and withdrawal from the right ventricle;
9. Subject with known intracardiac thrombus or vegetation on echocardiography;
10. Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult;
11. Subject has an active systemic infection or local infection at or around the insertion site;
12. Subject is involved in another clinical study that could influence the safety or outcome measures of this study.

Potentially eligible subjects who meet all inclusion criteria, and no exclusion criteria and who have consented to participate in the trial will be enrolled in the study. Sites will maintain a subject enrollment log. Subjects can withdraw from the study at any time.

Study success will be defined as success on the primary endpoints. Primary Study Endpoint Safety: Freedom from Serious ADEs [Time Frame: from insertion up to 30 days post-lead removal].

Performance: Mean Pacing Capture Threshold (>2V) [Time Frame: from insertion to Lead removal (Up to 7 days)].

Secondary Study Endpoint Safety: Freedom from ADEs [Time Frame: from insertion up to 30 days post-lead removal].

Performance: Mean Pacing Impedance (Ohms) [Time Frame: from insertion to Lead removal (Up to 7 days)].

Impedance measured while pacing the heart (in multiple postures). Performance: Sensed R-wave Amplitude [Time Frame: from insertion to Lead removal (Up to 7 days)].

Summary statistics for sensed R-wave amplitude for Lead from insertion through removal.