ECG Belt for CRT Response
Study Details
Study Description
Brief Summary
The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ECG Belt The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. |
Device: ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
|
| No Intervention: Control Arm Standard CRT through 6 months follow-up. |
Outcome Measures
Primary Outcome Measures
- Change in left ventricular end systolic volume (LVESV) from baseline to 6 months post-implant. [baseline to 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
-
Meets at least one of the following criteria: QRS duration < 150 ms, Prior documented Myocardial Infarction, Non-LBBB
-
LVEDD ≥ 55 mm, as determined by site
Exclusion Criteria:
-
Permanent/persistent AF or presenting with AF
-
Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
-
Currently implanted with IPG or ICD with > 10% RV pacing
-
Permanent complete AV block
-
Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
-
Less than 1 year life expectancy
-
Vulnerable adults
-
Younger than 18 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 2 | Yale School of Medicine | New Haven | Connecticut | United States | 06510 |
| 3 | MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 4 | University of Florida Health Shands Hospital | Gainesville | Florida | United States | 32608 |
| 5 | Florida Hospital Cardiovascular Research Institute | Orlando | Florida | United States | 32803-1248 |
| 6 | BayCare Health System | Tampa | Florida | United States | 33614-7101 |
| 7 | NorthShore University Health System | Evanston | Illinois | United States | 60201-1718 |
| 8 | Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
| 9 | Heartland Cardiology | Wichita | Kansas | United States | 67205-1138 |
| 10 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 11 | Advanced Cardiovascular Specialists | Shreveport | Louisiana | United States | 71105 |
| 12 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 13 | Saint Lukes Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 14 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 15 | Bryan Heart | Lincoln | Nebraska | United States | 68506 |
| 16 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07960-6136 |
| 17 | Atrium Health's Carolina Medical Center | Charlotte | North Carolina | United States | 28203-5867 |
| 18 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 19 | North Carolina Heart and Vascular | Raleigh | North Carolina | United States | 27607-7521 |
| 20 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 21 | Mount Carmel East | Columbus | Ohio | United States | 43213 |
| 22 | OhioHealth Research and Innovation Institute (OHRI) | Columbus | Ohio | United States | 43214 |
| 23 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73120 |
| 24 | Lehigh Valley Hospital- Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 25 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania | United States | 15213-2536 |
| 27 | Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 28 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0001 |
| 29 | Wellmont CVA Heart Institute | Kingsport | Tennessee | United States | 37660-7332 |
| 30 | Vanderbilt University medical Center | Nashville | Tennessee | United States | 37232-8802 |
| 31 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
| 32 | Texas Health Research & Education Institute | Fort Worth | Texas | United States | 76104 |
| 33 | The University of Vermont Medical Center | Burlington | Vermont | United States | 05401-1473 |
| 34 | Aurora St. Lukes | Milwaukee | Wisconsin | United States | 53215 |
| 35 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
| 36 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
| 37 | Montreal Heart Institute | Montréal | Quebec | Canada | H1T 1C8 |
| 38 | Policlinico Sant' Orsola - Malpighi | Bologna | Italy | 40138 | |
| 39 | Istituto Auxologico Italiano - Istituto Scientifico Ospedale San Luca | Milano | Italy | 20149 | |
| 40 | Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | Netherlands | 6229 HX |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Study Chair: ECG Belt for CRT Response Clinical Research Specialist, Medtronic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECG Belt for CRT Response