Clinical trial NCT02543281: Adaptive CRT Effect on Electrical Dyssynchrony
Official title: Adaptive CRT Effect on Electrical Dyssynchrony
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy
Heart Failure
Left Bundle Branch Block
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times.
timeFrame: baseline and 6 months after device implantation
Secondary outcomes:
measure: Change in 6-minute Walk Distance 6 Months Post CRT
timeFrame: baseline and 6 months after device implantation
measure: Change in MLHFQ Total Score
timeFrame: baseline and 6 months after device implantation
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Larisa Tereshchenko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haq KT, Rogovoy NM, Thomas JA, Hamilton C, Lutz KJ, Wirth A, Bender AB, German DM, Przybylowicz R, van Dam P, Dewland TA, Dalouk K, Stecker E, Nazer B, Jessel PM, MacMurdy KS, Zarraga IGE, Beitinjaneh B, Henrikson CA, Raitt M, Fuss C, Ferencik M, Tereshchenko LG. Adaptive Cardiac Resynchronization Therapy Effect on Electrical Dyssynchrony (aCRT-ELSYNC): A randomized controlled trial. Heart Rhythm O2. 2021 Jun 29;2(4):374-381. doi: 10.1016/j.hroo.2021.06.006. eCollection 2021 Aug.