Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial) (SENSE)

August 27, 2018 updated by: Weill Medical College of Cornell University

Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial

The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.

The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.

The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • Valhalla, New York, United States, 10532
        • Westchester Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State Wexner University Medical Center
      • Toledo, Ohio, United States, 43615
        • Promedica Heart and Vascular Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation

Description

Inclusion Criteria:

  • Fulfills standard indications for ICD implantation
  • Subject or legally authorized representative can provide written authorization per institutional requirements
  • Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
  • Able to comply with Home Monitoring

Exclusion Criteria:

  • Subject has prior diagnosis of atrial fibrillation or atrial flutter
  • Subject has need for atrial pacing
  • Subject unwilling or unable to give informed consent or participate in follow-up
  • Subject is unable to comply with Home Monitoring
  • Subject is pregnant
  • Subject has less than one year estimated life expectancy
  • Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
  • Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICD with DX system
Implantable cardioverter-defibrillator recipients with DX system
Device: ICD with DX system
Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
Other Names:
  • Biotronik Ilesto 7 VR-T ICD
  • Biotronik Lumax Smart S DX ICD lead
  • Future FDA-approved Biotronik DX-capable ICD and leads
Dual chamber ICD
Dual chamber implantable-cardioverter-defibrillator recipients (retrospective cohort from IMPACT study)
Single chamber ICD
Single chamber implantable cardioverter-defibrillator recipients (retrospective cohort from Cornell registry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial High Rate Episode
Time Frame: 1 year
Atrial high rate episode > 30 seconds in duration
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial Sensing (DX System)
Time Frame: 1 year
P wave amplitudes measured by DX lead system
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial High Rate Episode > 6 Minutes (DX System)
Time Frame: 1 year
Detection of AHRE > 6 minutes duration by DX lead system
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Biotronik, Inc.

Investigators

  • Principal Investigator: George Thomas, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401014661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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