Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

NCT01520714 | Terminated Results

• 1 other identifier: 009-067
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure (CHF); Cardiac Resynchronization Therapy (CRT); BiVentricular Implantable Cardioverter Defibrillator (BiVICD); Fraction

Outcome Measures

Primary Outcomes (1)

• Evidence of Change in Threshold of >1 Volt With Posture Changes

  6 months

Study Arms (2)

Medtronic passive fixation LV lead

EXPERIMENTAL

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

Medtronic 4195 Active Fixation LV Lead

EXPERIMENTAL

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

Interventions

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead DEVICE

1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Medtronic 4195 Active Fixation LV Lead; Medtronic passive fixation LV lead

Eligibility Criteria

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

You may qualify if:

• Greater than 18 years of age and able to provide informed consent
• Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
• Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
• Willingness to comply with the requirements of the protocol

You may not qualify if:

• Life expectancy of less than six months
• Plans for or significant possibility of pregnancy during the required follow-up window
• Significant cardiovascular surgery planned within six months following ICD implant

Sponsors & Collaborators

• Baylor Research Institute: lead
• Medtronic: collaborator

Study Sites (1)

The Heart Hospital in Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.

Results Point of Contact

• Title: Research Manager
• Organization: The Heart Hospital Baylor Plano

natalie.settele@baylorhealth.edu

469-814-4712

Study Officials

• James B DeVille, M.D.

  Baylor Research Institute - The Heart Hospital Baylor Plano

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: January 30, 2012
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (1)