Adaptive CRT Effect on Electrical Dyssynchrony
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/23/2018 |
| Start Date: | April 2015 |
| End Date: | May 2021 |
The purpose of this study is to better understand how adaptive cardiac resynchronization
therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the
left side of the heart, rather than to both sides, depending on how it senses the heart is
functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of
the heart. aCRT has already been approved by the FDA and is being used in patients now, but
it is not clear which patients it should be used in compared to normal CRT. This study will
include patients who are already scheduled to get a CRT device. The investigators will then
randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the
investigators will assess the electrical activity of the patients' hearts. After this time,
the patient and their doctors will be able to decide if they would like to change the type
CRT they have been designated.
therapy (aCRT) might benefit patients. aCRT works by sometimes giving stimulation to only the
left side of the heart, rather than to both sides, depending on how it senses the heart is
functioning. CRT without the adaptive algorithm works by giving stimulation to both sides of
the heart. aCRT has already been approved by the FDA and is being used in patients now, but
it is not clear which patients it should be used in compared to normal CRT. This study will
include patients who are already scheduled to get a CRT device. The investigators will then
randomize patients to the aCRT study arm or to the CRT study arm. After 6 months, the
investigators will assess the electrical activity of the patients' hearts. After this time,
the patient and their doctors will be able to decide if they would like to change the type
CRT they have been designated.
Inclusion Criteria:
- Patient has a standard class I or class II indications for CRT-P or CRT-D implantation
in accordance with ACC/AHA/HRS guidelines (2012 ACCF/AHA/HRS Focused Update
Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac
Rhythm Abnormalities)2.At least 18 years of age at the time of consent
- Is willing and able to comply with the protocol
Exclusion Criteria:
- Chronic atrial arrhythmias defined as: "Atrial fibrillation is permanent when it has
resisted all attempts to restore sinus rhythm or when the physician and patient decide
that no such attempt should be made."
- Patient has ever had a previous or has an existing CRT system, ICD, or pacemaker.
- GFR <30ml/min
- Patient has had unstable angina, acute myocardial infarction, coronary artery bypass
graft surgery, or percutaneous transluminal coronary angioplasty within 30 days prior
to study enrollment
- Patient has primary valvular disease and is indicated for valve repair or replacement
- Patient is enrolled in ≥1 concurrent studies that would confound the study results
(any other interventional trial)
- Patient is pregnant or of childbearing potential and not on a reliable form of birth
control. All women of child-bearing potential must undergo a pregnancy test.
- Patient status post heart transplant
- Patient has been classified as NYHA functional class IV within 3 months prior to study
enrollment
- concomitant conditions other than cardiac diseases that were associated with a higher
likelihood of death during 1 year after enrollment
- Patient, legal guardian or authorized representative is unable or unwilling to
cooperate or give written informed consent
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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