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Conduction Defect clinical trials

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NCT ID: NCT05633394 Recruiting - Conduction Defect Clinical Trials

Subcostal Temporary Extravascular Pacing V Study

STEP V
Start date: January 23, 2023
Phase: N/A
Study type: Interventional

The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System over a two-day use period with Subjects restricted to bedrest. Lead performance will also be evaluated without bedrest restrictions in the limited period shortly before lead removal on the last follow-up day.

NCT ID: NCT05610033 Recruiting - Conduction Defect Clinical Trials

Pilot evaluatIon Of NovEl tEmpoRary ExtraVascular PACING (PIONEER EV PACING) Study

Start date: September 19, 2023
Phase: N/A
Study type: Interventional

The PIONEER EV PACING Study is prospective, multi-center, acute (in-hospital), single-arm, pilot study. The study objective is to characterize preliminary safety and performance of the AtaCor EV Temporary Pacing Lead System when used as intended for clinical use as a temporary pacing lead.

NCT ID: NCT05457673 Completed - Conduction Defect Clinical Trials

Subcostal Temporary Extravascular Pacing IV (STEP IV) Study

STEP IV
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System to support the development of a future pivotal study with an indication limited to a maximum of 7 days.

NCT ID: NCT04538287 Completed - Conduction Defect Clinical Trials

AtaCor Subcostal Temporary Extravascular Pacing III Study

STEP III
Start date: October 3, 2020
Phase: N/A
Study type: Interventional

Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.

NCT ID: NCT04374929 Completed - Conduction Defect Clinical Trials

Subcostal Temporary Extracardiac Pacing II Study

STEP II
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for stabilizing AtaCor Temporary Pacing System electrical measurements over a two (2) to seven (7) day period. The three treatments are (1) Negative Pressure Wound Therapy, (2) Anti-Inflammatory Glucocorticoid and (3) increased electrode spacing. A control arm with no additional treatment is also included. 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. Appropriate sensing and pacing capture will be ascertained from ECG Holter Monitor recordings during periods of in-hospital ambulation.

NCT ID: NCT04096365 Completed - Conduction Defect Clinical Trials

Subcostal Temporary Extracardiac Pacing Study

STEP
Start date: August 25, 2019
Phase: N/A
Study type: Interventional

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.