SPIKE FLOW Endocardial Lead Safety and Performance Study

NCT07820072 | Recruiting DMC

• 1 other identifier: IT-26-03-056934
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Asystole; Bradycardia; AV Block; Ventricular Tachyarrhythmia; Acute Myocardial Infarction (AMI)

Keywords

acute myocardial infaction; asystole; bradycardia; AV block; Ventricular tachyarrhytmias; Overdrive suppression of tachyarrhytmias; High frequency pacing during percutaneous procedures; Cardiac surgery requiring backup pacing, surveillance of cardiac activity

Outcome Measures

Primary Outcomes (2)

• Safety: Freedom from Severe ADEs

  from insertion up to 30 days post-lead removal

• Performance: Mean Pacing Capture Threshold (>2V)

  from insertion to Lead removal (Up to 7 days)

Secondary Outcomes (3)

• Safety: Freedom from ADEs

  from insertion up to 30 days post-lead removal

• Performance: Mean Pacing Impedance (Ohms)

  from insertion to Lead removal (Up to 7 days)

• Performance: Sensed R-wave Amplitude

  from insertion to Lead removal (Up to 7 days)

Study Arms (1)

experimental single-arm

EXPERIMENTAL

Procedure: Lead insertion; Procedure: lead removal

Interventions

Lead insertion PROCEDURE

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.

experimental single-arm

lead removal PROCEDURE

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

experimental single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FIAB SpA: lead

Study Sites (3)

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Bari, 70021, Italy

NOT YET RECRUITING

Ospedale del Cuore 'G. Pasquinucci' Fondazione Toscana 'Gabriele Monasterio'

Massa, Massa-Carrara, 54100, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Heart Arrest; Bradycardia; Atrioventricular Block; Tachycardia, Ventricular

Interventions

Device Lead Extraction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease; Tachycardia

Intervention Hierarchy (Ancestors)

Device Removal; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)