Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/12/2017 |
| Start Date: | June 11, 2017 |
| End Date: | February 27, 2020 |
| Contact: | Eric Johnson, MD |
| Email: | eric.johnson@sterncardio.com |
| Phone: | 901-271-1000 |
IMPROVE RESPONSE is a physician initiated research study. It is a prospective,
non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in
heart failure (HF) observational study. The purpose of this clinical study is to test the
hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm
have an incremental benefit in improving CRT response in a chronic CRT non responder
population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition
compared to CRT devices with traditional biventricular pacing delivery methods at generator
replacement.
non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in
heart failure (HF) observational study. The purpose of this clinical study is to test the
hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm
have an incremental benefit in improving CRT response in a chronic CRT non responder
population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition
compared to CRT devices with traditional biventricular pacing delivery methods at generator
replacement.
Inclusion Criteria:
- Normal AV conduction (SAV<220 ms or PAV<270 MS)
- Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female),
QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2,
V5, V6 and I and aVL.)
- Patient and/or physician assessment or unchanged or worsened heart failure status at
the time of recommended replacement time (RRT) for previous CRT device.
- Sinus Rhythm at the time of enrollment
Exclusion Criteria:
- Moderate to severe Aortic Stenosis
- Moderate to severe Mitral Regurgitation
- Patient age <18 years old
- AF burden >15%
- Severe pulmonary disease requiring supplemental oxygen use
- ESRD
- System Modification at RRT Generator Changeout
- AdaptivCRT prior to enrollment
- Expected patient longevity < 1 year
- Persistant or chronic atrial fibriliation
- Women who are pregnant or who plan to become pregnant during the clinical trial
We found this trial at
1
site
Germantown, Tennessee 38138
Principal Investigator: Eric Johnson, MD
Phone: 901-271-4165
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