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

Primary Purpose

Arrythmia, Bradycardia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
KronoSafe® System
Sponsored by
ICU Medical Technologies S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arrythmia focused on measuring Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital General Universitario de Alicante Dr.BalmisRecruiting
  • Hospital Universitari Vall D'HebronRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temporary Cardiac Pacing with Active-Fixation Leads

Arm Description

Outcomes

Primary Outcome Measures

Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Ventricular R wave detection
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Lead impedance detection
Lead impedance, measured in ohms with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Right ventricle threshold detection
Right ventricle threshold, measured in volts with pacemaker generator programmer
Lead displacement detection
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Capture failure detection
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Sensing failure detection
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Lead insulation breakdown detection
Visual observation of lead insulation breakdown by clinical examination
Generator detachment detection
Visual observation of generator detachment by clinical examination. removal of the generator from the casing.
Cardiac peroration detection
New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25%

Secondary Outcome Measures

Detection of Bacteremia
Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Detection of Agitation
Record of antipsychotic and anxiolytic treatment of the patient

Full Information

First Posted
March 28, 2022
Last Updated
January 19, 2023
Sponsor
ICU Medical Technologies S.L.
Collaborators
Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT05351658
Brief Title
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Acronym
TEMPACE
Official Title
Safety and Effectiveness of the External Fastening System for Temporary Active Fixation Pacemakers (TEMPACE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ICU Medical Technologies S.L.
Collaborators
Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Bradycardia
Keywords
Pacemaker, Cardiac pacing, Bradycardia, Arrhythmia, Treatment outcome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study will be carried out in an Arrhythmia Unit or Intensive Care Unit. Patients who need urgent temporary cardiac pacing due to bradycardia, or elective pacing to prevent heart rhythm disturbances during high-risk arrhythmia interventions, such as transcatheter aortic valve implantation (TAVR), alcoholic septal ablations, etc., will be included. After the temporary pacemaker implantation with active fixation electrode in a correct way, the KronoSafe® external pacemaker fixation system will be placed. The correct functioning of the system (R wave detection, lead impedance and right ventricle threshold) will be checked at 24 hours and every other day until the end of cardiac stimulation. During temporary pacing, associated complications are going to be recorded: lead displacement, capture or sensing failure, generator or lead detachment, and cardiac perforation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temporary Cardiac Pacing with Active-Fixation Leads
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
KronoSafe® System
Intervention Description
All patients included in the study will have a temporary pacemaker with active fixation leads, held by the KronoSafe® fixation system.
Primary Outcome Measure Information:
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
Immediately after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
Immediately after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
Immediately after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
24 hours after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 3 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 5 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 7 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 9 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 11 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 13 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 15 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 17 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 19 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 21 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 23 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 25 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 27 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
day 29 after the procedure of lead implantation
Title
Ventricular R wave detection
Description
Ventricular R wave, measured in millivolts with pacemaker generator programmer
Time Frame
Immediately before the procedure of lead removal
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
24 hours after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 3 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 5 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 7 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 9 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 11 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 13 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 15 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 17 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 19 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 21 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 23 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 25 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 27 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
day 29 after the procedure of lead implantation
Title
Lead impedance detection
Description
Lead impedance, measured in ohms with pacemaker generator programmer
Time Frame
Immediately before the procedure of lead removal
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
24 hours after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 3 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 5 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 7 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 9 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 11 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 13 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 15 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 17 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 19 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 21 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 23 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 25 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 27 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
day 29 after the procedure of lead implantation
Title
Right ventricle threshold detection
Description
Right ventricle threshold, measured in volts with pacemaker generator programmer
Time Frame
Immediately before the procedure of lead removal
Title
Lead displacement detection
Description
Visual observation of 2 cm electrode displacement through vein acces by clinical examination
Time Frame
Immediately before the procedure of lead removal
Title
Capture failure detection
Description
Right ventricle threshold above 5 volts during 1 millisecond, measured with pacemaker generator programmer.
Time Frame
Immediately before the procedure of lead removal
Title
Sensing failure detection
Description
Ventricular R wave below 1 volt, measured with pacemaker generator programmer
Time Frame
Immediately before the procedure of lead removal
Title
Lead insulation breakdown detection
Description
Visual observation of lead insulation breakdown by clinical examination
Time Frame
Immediately before the procedure of lead removal
Title
Generator detachment detection
Description
Visual observation of generator detachment by clinical examination. removal of the generator from the casing.
Time Frame
Immediately before the procedure of lead removal
Title
Cardiac peroration detection
Description
New pericardial effusion detected by Echocardiography with signs of cardiac tamponade: respiratory variation of transmitral filling flow greater than 25%
Time Frame
Immediately before the procedure of lead removal
Secondary Outcome Measure Information:
Title
Detection of Bacteremia
Description
Isolation of the same bacteria in the pacemaker lead and 2 blood cultures from the patient
Time Frame
Immediately after the procedure of lead removal
Title
Detection of Agitation
Description
Record of antipsychotic and anxiolytic treatment of the patient
Time Frame
Immediately after the procedure of lead removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raimundo Vicente, MD
Phone
+34 965933000
Email
tempace@icumedic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimundo Vicente, MD
Organizational Affiliation
Intensive Care Physician at Dr. Balmis University Hospital (Alicante)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario de Alicante Dr.Balmis
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34918044
Citation
Vicente-Miralles R, Martin-Langerwerf DA, Nunez-Martinez JM, Marco-Juan A, Sangio-Ferreyros AD, Davila-Arias A, Montes-Jacobo L, Barrios V, Palazon-Bru A, Gil-Guillen VF, Bertomeu-Gonzalez V. A new fastening system for temporary pacing with active-fixation leads: effectiveness and safety. Eur Heart J Acute Cardiovasc Care. 2022 Mar 16;11(3):224-229. doi: 10.1093/ehjacc/zuab119.
Results Reference
result
PubMed Identifier
16580542
Citation
Zei PC, Eckart RE, Epstein LM. Modified temporary cardiac pacing using transvenous active fixation leads and external re-sterilized pulse generators. J Am Coll Cardiol. 2006 Apr 4;47(7):1487-9. doi: 10.1016/j.jacc.2006.01.006. Epub 2006 Mar 15. No abstract available.
Results Reference
result
PubMed Identifier
23482613
Citation
Kawata H, Pretorius V, Phan H, Mulpuru S, Gadiyaram V, Patel J, Steltzner D, Krummen D, Feld G, Birgersdotter-Green U. Utility and safety of temporary pacing using active fixation leads and externalized re-usable permanent pacemakers after lead extraction. Europace. 2013 Sep;15(9):1287-91. doi: 10.1093/europace/eut045. Epub 2013 Mar 12.
Results Reference
result
PubMed Identifier
12954959
Citation
Betts TR. Regional survey of temporary transvenous pacing procedures and complications. Postgrad Med J. 2003 Aug;79(934):463-5. doi: 10.1136/pmj.79.934.463.
Results Reference
result

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

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