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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02186704
• Collaborator: Biotronik, Inc. (Industry)
• Enrollment: 450
• Locations: 8
• Actual Duration (Months): 48
• Patients Per Site: 56.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: ICD with DX system

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 Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Atrial High Rate Episode [1 year]

   Atrial high rate episode > 30 seconds in duration

Secondary Outcome Measures

1. Atrial Sensing (DX System) [1 year]

   P wave amplitudes measured by DX lead system

Other Outcome Measures

1. Atrial High Rate Episode > 6 Minutes (DX System) [1 year]

   Detection of AHRE > 6 minutes duration by DX lead system

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Weill Cornell Medical College	New York	New York	United States	10021
4	Westchester Medical Center	Valhalla	New York	United States	10532
5	The Ohio State Wexner University Medical Center	Columbus	Ohio	United States	43210
6	Promedica Heart and Vascular Institute	Toledo	Ohio	United States	43615
7	Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
8	Vanderbilt University	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Biotronik, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02186704
• Other Study ID Numbers: 1401014661
• First Posted: Jul 10, 2014
• Last Update Posted: Aug 28, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Weill Medical College of Cornell University: Atrial Fibrillation; Implantable Defibrillators; Implanted Electrodes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 28, 2018