SPIKE FLOW Endocardial Lead Safety and Performance Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFIAB SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Lead insertion
Procedure/SurgeryImplantation 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.
lead removal
Procedure/SurgeryRemoval 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
Treatment groups
131 Participants
are divided into 1 treatment groupGroup A: experimental single-armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety: Freedom from Severe ADEs
Time frame
from insertion up to 30 days post-lead removal2
Performance: Mean Pacing Capture Threshold (>2V)
Time frame
from insertion to Lead removal (Up to 7 days)Secondary outcomes
1
Safety: Freedom from ADEs
Time frame
from insertion up to 30 days post-lead removal2
Performance: Mean Pacing Impedance (Ohms)
Impedance measured while pacing the heart (in multiple postures)
Time frame
from insertion to Lead removal (Up to 7 days)3
Performance: Sensed R-wave Amplitude
Summary statistics for sensed R-wave amplitude for Lead from insertion through removal
Time frame
from insertion to Lead removal (Up to 7 days) Source ClinicalTrials.gov