SPIKE FLOW endocardial pacing lead safety and performance study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-randomized, single-arm study evaluates the safety and performance of the SPIKE FLOW temporary endocardial pacing leads across multiple centers in Italy. Primary endpoints look at safety as freedom from Serious Adverse Events and pacing performance via mean capture threshold. Secondary endpoints include freedom from Adverse Events, impedance, and sensed R-wave amplitude. Approximately 131 adults undergoing procedures requiring temporary pacing will be enrolled over about one year with follow-up visits around lead insertion and removal.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;
* Subject is at least 18 years of age;
* Subject provides written informed consent to the study.

Exclusion Criteria:

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

Where it's running

• Ospedale del Cuore 'G. Pasquinucci' Fondazione Toscana 'Gabriele Monasterio'
  Massa, Massa-Carrara, Italy Recruiting
• Azienda Ospedaliero Universitaria Pisana
  Pisa, Pisa, Italy Recruiting
• Ospedale Generale Regionale "F. Miulli"
  Acquaviva delle Fonti, Bari, Italy Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.