Subcostal Temporary Extracardiac Pacing Study

NCT04096365 | Completed Results FDA Device

• 1 other identifier: DOC-10052
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events. Performance will be evaluated through (1) the incidence of successful StealthTrac Lead placement using the MACH I Delivery Tool, (2) electrical performance measurements, such as pacing capture thresholds, sensed R-wave amplitudes, pacing impedance and skeletal muscle stimulation at rest. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

Conditions

Conduction Defect

Keywords

Temporary; Ventricular; Pacing

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.

  Up to 2 days post insertion

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 Lead DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (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.
• Physically and mentally capable of providing informed consent.
• At least 18 years of age or of legal age to provide consent as required by local and national requirements.

You may not qualify if:

• Contraindicated or clinically unsuitable for transvenous lead placement;
• Implanted with an implantable cardioverter defibrillator (ICD) or transvenous defibrillation lead at the time of enrollment;
• History of a prior sternotomy (median or partial);
• History of prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium;
• History of significant anatomic derangement of the thorax (e.g., pectus excavatum), prior chest radiation therapy or other reasons which may cause pericardial adhesions or complicate the AtaCor Temporary Pacing System insertion procedure;
• History of pericardial disease, pericarditis or mediastinitis;
• History of chronic obstructive pulmonary disease (COPD);
• NYHA functional classification IV at the time of enrollment;
• History of congenital heart disease;
• Patients with circumstances that prevent data collection or follow-up, including conditions that prevent ambulation and testing in multiple postures;
• BMI ≥ 35 kg/m2;
• History of allergies to any study device components;
• Pregnant or lactating (current or anticipated during study follow up); and
• Participation in any concurrent study without prior, written approval from the Sponsor.

Sponsors & Collaborators

• AtaCor Medical, Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

alan@atacor.com

949 391 2252

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

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
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)