SALT

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180570
First received: September 15, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Bradycardia
Device: FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scandinavian Atrial Lead Trial

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.

Secondary Outcome Measures:
  • 1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties

Estimated Enrollment: 385
Study Start Date: January 1997
Estimated Study Completion Date: January 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • Patients who previously went through heart surgery should be excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180570

Locations
Sweden
Sahlgrenska Sjukhuset i Göteborg Sweden,
Goteborg, Sweden
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: charles kennergren Sahlgrenska Sjukhuset i Göteborg Sweden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180570     History of Changes
Other Study ID Numbers: SALT-2
Study First Received: September 15, 2005
Last Updated: September 15, 2005
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014