SPIKE FLOW Endocardial Lead Safety and Performance Study (SPIKE FLOW)

September 15, 2026 updated by: FIAB SpA

A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead

The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead.

Primary objectives are to assess:

  • safety in terms of freedom from Serious Adverse Events(SADEs);
  • performance in terms of Mean Pacing Capture Threshold.

Secondary objectives are to assess:

  • safety in terms of freedom from Adverse Events (ADEs);
  • performance in terms of Mean Pacing Impedance;
  • performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy.

The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bari
      • Acquaviva delle Fonti, Bari, Italy, 70021
        • Not yet recruiting
        • Ospedale Generale Regionale "F. Miulli"
        • Contact:
    • Massa-Carrara
      • Massa, Massa-Carrara, Italy, 54100
        • Not yet recruiting
        • Ospedale del Cuore 'G. Pasquinucci' Fondazione Toscana 'Gabriele Monasterio'
        • Contact:
          • Dr. Marco Ciardetti
          • Phone Number: +39 0503153711
          • Email: mciard@ftgm.it
    • Pisa
      • Pisa, Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental single-arm
Procedure: Lead insertion

Implantation of the device should be performed as per the manufacturer's Instructions for Use (IFU).

Procedural details will be captured as appropriate on the procedural worksheets. Any Adverse Events or Device Deficiencies observed shall also be recorded.

The following tests and examinations must be performed immediately after lead insertion:

  • Physical examination and vital signs (includes Pulse, Blood Pressure);
  • Laboratory testing per site standard practice;
  • Electrocardiogram (ECG);
  • Transthoracic Echocardiogram (TTE);
  • Adverse events and device deficiencies assessment.
Procedure: lead removal

Removal of the device should be performed as per the manufacturer's IFU. Procedural details will be captured as appropriate on the procedural worksheets. Any adverse events or device deficiencies observed shall also be recorded.

The following tests and examinations must be performed immediately after lead removal:

  • Physical examination and vital signs (includes Pulse, Blood Pressure);
  • Laboratory testing per site standard practice;
  • ECG;
  • TTE;
  • Adverse event and device deficiencies assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Freedom from Severe ADEs
Time Frame: from insertion up to 30 days post-lead removal
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)
from insertion to Lead removal (Up to 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Freedom from ADEs
Time Frame: from insertion up to 30 days post-lead removal
from insertion up to 30 days post-lead removal
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
from insertion to Lead removal (Up to 7 days)
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)
from insertion to Lead removal (Up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FIAB SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 15, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-26-03-056934

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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