SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2006-01-31

Brief Summary

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Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

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Detailed Description

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This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Conditions

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Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.