Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE) (TEMPACE)

April 16, 2025 updated by: ICU Medical Technologies S.L.
Temporary cardiac pacing with active-fixation leads (TPAFL) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. However, TPAFL requires the off-label (non-certificated) use of Pacemaker leads and generators. It is designed a fastening system to ensure the safety and efficacy of the procedure: the KronoSafe System®. The aim of this study is to demonstrate the safety and effectiveness of the KronoSafe System® for temporary pacing in a series of patients receiving TPAFL.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante Dr.Balmis
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient older than 18 years.
  • Need for temporary cardiac stimulation
  • Temporary active fixation pacemaker implantation through left or right jugular access.
  • Signature of informed consent
  • Correct functioning of the electrode after the implantation: sensing of the R wave above 5 millivolts. Ventricular pacing threshold below 1 volt. Electrode impedance between 400-1200 Ohm.
  • Pacemaker programming with stimulation output at 5 volts intensity and 1 millisecond pulse duration.
  • Placement of the KronoSafe® fastening system after electrode implantation.

Exclusion Criteria:

  • Complication during the procedure: pneumothorax, hematoma at the puncture site, cardiac perforation, accidental arterial puncture or other that, in the investigator's opinion, poses an added risk of pacemaker dysfunction.
  • Need to transfer the patient to another center with loss of follow-up.
  • Absence of surveillance through continuous electrocardiographic monitoring with detection of arrhythmic events.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Temporary Cardiac Pacing with Active-Fixation Leads
Device: KronoSafe® System
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventricular R wave detection
Time Frame: Immediately after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Immediately after the procedure of lead implantation
Lead impedance detection
Time Frame: Immediately after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
Immediately after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: Immediately after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
Immediately after the procedure of lead implantation
Ventricular R wave detection
Time Frame: 24 hours after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
24 hours after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 3 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 3 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 5 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 5 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 7 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 7 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 9 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 9 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 11 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 11 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 13 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 13 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 15 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 15 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 17 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 17 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 19 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 19 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 21 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 21 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 23 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 23 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 25 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 25 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 27 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 27 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: day 29 after the procedure of lead implantation
Ventricular R wave, measured in millivolts with pacemaker generator programmer
day 29 after the procedure of lead implantation
Ventricular R wave detection
Time Frame: Immediately before the procedure of lead removal
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Immediately before the procedure of lead removal
Lead impedance detection
Time Frame: 24 hours after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
24 hours after the procedure of lead implantation
Lead impedance detection
Time Frame: day 3 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 3 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 5 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 5 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 7 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 7 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 9 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 9 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 11 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 11 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 13 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 13 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 15 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 15 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 17 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 17 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 19 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 19 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 21 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 21 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 23 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 23 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 25 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 25 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 27 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 27 after the procedure of lead implantation
Lead impedance detection
Time Frame: day 29 after the procedure of lead implantation
Lead impedance, measured in ohms with pacemaker generator programmer
day 29 after the procedure of lead implantation
Lead impedance detection
Time Frame: Immediately before the procedure of lead removal
Lead impedance, measured in ohms with pacemaker generator programmer
Immediately before the procedure of lead removal
Right ventricle threshold detection
Time Frame: 24 hours after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
24 hours after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 3 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 3 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 5 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 5 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 7 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 7 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 9 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 9 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 11 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 11 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 13 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 13 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 15 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 15 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 17 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 17 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 19 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 19 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 21 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 21 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 23 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 23 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 25 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 25 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 27 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 27 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: day 29 after the procedure of lead implantation
Right ventricle threshold, measured in volts with pacemaker generator programmer
day 29 after the procedure of lead implantation
Right ventricle threshold detection
Time Frame: Immediately before the procedure of lead removal
Right ventricle threshold, measured in volts with pacemaker generator programmer
Immediately before the procedure of lead removal
Lead displacement detection
Time Frame: Immediately before the procedure of lead removal
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Immediately before the procedure of lead removal
Capture failure detection
Time Frame: Immediately before the procedure of lead removal
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Immediately before the procedure of lead removal
Sensing failure detection
Time Frame: Immediately before the procedure of lead removal
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Immediately before the procedure of lead removal
Lead insulation breakdown detection
Time Frame: Immediately before the procedure of lead removal
Visual observation of lead insulation breakdown by clinical examination
Immediately before the procedure of lead removal
Generator detachment detection
Time Frame: Immediately before the procedure of lead removal
Visual observation of generator detachment by clinical examination. removal of the generator from the casing.
Immediately before the procedure of lead removal
Cardiac peroration detection
Time Frame: Immediately before the procedure of lead removal
New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25%
Immediately before the procedure of lead removal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Detection of Bacteremia
Time Frame: Immediately after the procedure of lead removal
Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Immediately after the procedure of lead removal
Detection of Agitation
Time Frame: Immediately after the procedure of lead removal
Record of antipsychotic and anxiolytic treatment of the patient
Immediately after the procedure of lead removal

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ICU Medical Technologies S.L.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Miguel Hernandez de Elche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raimundo Vicente, MD, Intensive Care Physician at Dr. Balmis University Hospital (Alicante)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TEMPACE

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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