aCRT-ELSYNC: Adaptive CRT Effect on Electrical Dyssynchrony
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: aCRT Off The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm. |
Device: Conventional Cardiac Resynchronization Therapy
CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
Other Names:
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| Experimental: aCRT On The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm. |
Device: Adaptive cardiac resynchronization therapy
The adaptive cardiac resynchronization therapy (aCRT) algorithm 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Regression slope of Electrical dyssynchrony index [6 months after device implantation]
Regression slope of Electrical Dyssynchrony Index values measured on epicardial activation map 6 months post-CRT, regressed against Electrical Dyssynchrony Index values measured by ECGi prior CRT.
- Difference in regression slopes of SAI QRST against EDI vs. QRS duration against EDI [6 months after device implantation]
Difference in regression slopes of SAI QRST against Electrical Dyssynchrony Index vs. QRS duration against Electrical Dyssynchrony Index prior CRT and 6 months post-CRT
Secondary Outcome Measures
- Regression slope of surface ECG and intracardiac spatial QRS-T angle and VCG QRS and T loops morphology [6 months after device implantation]
Surface ECG and intracardiac spatial QRS-T angle and QRS & T loops morphological characteristics measured 6 months post-CRT regressed against the same measures prior CRT
- Clinical Composite Score [6 months after device implantation]
End-point adjudication committee will adjudicate all available information and decide whether patient (1) improved; (2) worsened; (3) not changed, based on: 6-minute walk distance change, NYHA class change, heart failure hospitalization, death, CRT removal (or turned OFF), MLHFQ and SF-36 score change, LVEF / LVESV change on echocardiogram
- Reverse electrical remodeling [6 months after device implantation]
Shortened duration of non-paced QRS complex 6 months post-CRT greater than or equal 10 ms
- regression slope of PeRV1 interval [6 months after device implantation]
PeRV1 interval measured 6 months post- CRT, regressed against PeRV1 interval measured prior CRT
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Is willing and able to comply with the protocol
Exclusion Criteria:
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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."
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Patient has ever had a previous or has an existing CRT system, ICD, or pacemaker.
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GFR <30ml/min
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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
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Patient has primary valvular disease and is indicated for valve repair or replacement
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Patient is enrolled in ≥1 concurrent studies that would confound the study results (any other interventional trial)
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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.
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Patient status post heart transplant
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Patient has been classified as NYHA functional class IV within 3 months prior to study enrollment
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concomitant conditions other than cardiac diseases that were associated with a higher likelihood of death during 1 year after enrollment
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Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Larisa Tereshchenko
Investigators
- Principal Investigator: Larisa Tereshchenko, MD, PhD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-11299