Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biotronik, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD with DX system | Implantable cardioverter-defibrillator recipients with DX system |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD with DX system | Device | Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole. |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial High Rate Episode | Atrial high rate episode > 30 seconds in duration | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Sensing (DX System) | P wave amplitudes measured by DX lead system | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial High Rate Episode > 6 Minutes (DX System) | Detection of AHRE > 6 minutes duration by DX lead system | 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects with standard indications for implantable cardioverter-defibrillator implantation and no prior history of atrial fibrillation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Thomas, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Massachusetts General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Westchester Medical Center | Valhalla | New York | 10532 | United States |
| The Ohio State Wexner University Medical Center | Columbus | Ohio | 43210 | United States |
| Promedica Heart and Vascular Institute | Toledo | Ohio | 43615 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
Not provided
Not provided