Trials Sponsors Conditions Drugs Pricing

Conditions

Conduction Defect

Keywords

TemporaryVentricularPacing

Outcome Measures

Primary Outcomes (5)

Safety Outcome: Number of Subjects Experiencing an Adverse Device Effect
Safety will be evaluated through analysis of all Adverse Device Effects
30 days
Performance Outcome: Mean Pacing Capture Threshold (V)
Minimum current required to pacing the heart (in multiple postures)
Up to 2 days post insertion
Performance Outcome: Mean Pacing Impedance (Ohms)
Impedance measured while pacing the heart (in multiple postures)
Up to 2 days post insertion
Performance Outcome: Mean R-Wave Amplitude (mV)
R-Wave amplitudes measured while sensing the heart (in multiple postures)
Up to 2 days post insertion
Performance Outcome: % of R-R Intervals With Appropriate Pacing and Sensing During Activity
ECG Holter Recordings obtained during periods of rest and in-hospital activity. The % of R-R intervals with appropriate pacing is calculated as the number of paced intervals that demonstrate pacing capture / the total number of pacing intervals. The % of R-R intervals with appropriate sensing is calculated as the number of intervals where pacing is appropriately delivered or inhibited (depending on the programmed settings of the pacemaker) / the total number of R-R intervals. The outcomes are presented a % of intervals and not an average of the percentages observed across patients.

Other Outcomes (2)

Paced QRS Duration (ms)
1 day after insertion
Echocardiographic Assessment of Left Ventricular Stroke Volume During Pacing (mL)
2 days after insertion

Study Arms (1)

Subcostal temporary extracardiac pacing lead

EXPERIMENTAL

All subjects will receive a subcostal temporary extracardiac pacing lead for a minimum of 48 hours in-hospital and undergo all protocol testing.

Device: Subcostal Temporary Extracardiac Pacing Lead

Interventions

Subcostal Temporary Extracardiac Pacing LeadDevice

The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.

Subcostal temporary extracardiac pacing lead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Indicated for closed-chest cardiac invasive procedure with the potential for intra-procedural or post-procedural bradycardia and willing to be hospitalized for a minimum of 2 days post procedure.
Examples of such procedures include: transfemoral transcatheter aortic valve replacement (TAVR), balloon valvuloplasty, permanent pacemaker implantation and pacing lead extractions/revisions.

Sponsors & Collaborators

AtaCor Medical, Inc.
Industrylead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Alan Marcovecchio, Vice President, Clinical Affairs
Organization: AtaCor Medical, Inc.

Study Officials

Martin Burke, D.O.
AtaCor Medical
PRINCIPAL INVESTIGATOR
Adrian Ebner, M.D.
Sanatorio Italiano
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

August 25, 2019

Actual (reported)

Subcostal Temporary Extracardiac Pacing Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Other Outcomes (2)

Study Arms (1)

Subcostal temporary extracardiac pacing lead

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Other Outcomes (2)

Study Arms (1)

Subcostal temporary extracardiac pacing lead

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations