Adaptive CRT Effect on Electrical Dyssynchrony (aCRT-ELSYNC)

Larisa Tereshchenko

Status: Completed

Conditions: Cardiomyopathy; Left Bundle Branch Block; Heart Failure

Treatments: Device: Conventional Cardiac Resynchronization Therapy; Device: Adaptive cardiac resynchronization therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02543281

IRB-11299

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 3 patient groups

aCRT Off

Active Comparator group

Description:

The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm.

Treatment:

Device: Conventional Cardiac Resynchronization Therapy

aCRT On

Experimental group

Description:

The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm.

Treatment:

Device: Adaptive cardiac resynchronization therapy

Registry arm

No Intervention group

Description:

Participants who are not eligible for the randomization because of the implantation of the device that is not capable of delivering aCRT. The team of clinical care providers makes such a clinical decision acting in the patient's best interests.