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
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to collect and analyze electrical measurements, timing, and signals from a CRT-D device in heart failure patients who either already have an implanted left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial pressure sensor and a CRT-D device. These devices may be placed at the same time or separately (staged procedure) at the discretion of the investigator. A comparison will be made between the information gathered from the CRT-D system and the information gathered by the left atrial pressure sensor.
This is a multi-center feasibility study.
.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartPOD™ System with Cardiac Resynchronization Therapy | All patients will receive both a HeartPod device and a CRT-D device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy | Device | Pacing of the left ventricle to resynchronize ventricular contraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine which heart failure monitoring feature acquired by the CRT device correlates most closely with simultaneously measured left ventricular filling pressure, as measured by left atrial pressure. | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with class III heart failure and a CRT-D device implanted.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Troughton, MD | Christchurch Hospital - Christchurch, New Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24502608 | Derived | Chan WY, Blomqvist A, Melton IC, Noren K, Crozier IG, Benser ME, Eigler NL, Gutfinger D, Troughton RW. Effects of AV delay and VV delay on left atrial pressure and waveform in ambulant heart failure patients: insights into CRT optimization. Pacing Clin Electrophysiol. 2014 Jul;37(7):810-9. doi: 10.1111/pace.12362. Epub 2014 Feb 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| HeartPOD™ System | Device | Left atrial pressure monitoring. |
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Sanger Clinic | Charlotte | North Carolina | 28203 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Medical Univserity of South Carolina | Charleston | South Carolina | 29403 | United States |
| Christchurch Hospital | Christchurch | New Zealand |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
Not provided
Not provided