Evaluation of Left Ventricular AutoThreshold

NCT00812201 | Completed

• 1 other identifier: CRRT081908H
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study will collect data on a new feature for future heart failure devices via an external non-implantable system.

Conditions

Heart Failure

Keywords

Heart failure; auto threshold; pacing; CRT-P or CRT-D recipients, threshold measurements

Outcome Measures

Primary Outcomes (1)

• The objective of this study is to collect data to characterize the performance of the LVAT feature.

  Implant

Study Arms (1)

1

Device: No intervention is used. Collection of signals only.

Interventions

No intervention is used. Collection of signals only. DEVICE

Device received per standard of care.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
• Patients who are willing and capable of participating in all testing associated with this study
• Patients who are 18 or above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

• Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
• Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
• Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
• Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
• Patients with a prosthetic mechanical tricuspid heart valve
• Women who are pregnant

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth L. Ellenbogen, M.D.

  Virginia Commonwealth University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

US (2)