Adaptive CRT Effect on Electrical Dyssynchrony

NCT02543281 | Completed Results DMC

• 1 other identifier: IRB-11299
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Heart Failure; Left Bundle Branch Block

Outcome Measures

Primary Outcomes (1)

• Change in Ventricular Electrical Uncoupling (VEU), Calculated as the Difference in Difference Between the Mean Left Ventricular (LV) and Right Ventricular (RV) Activation Times.

  LV and RV activation time values were measured on reconstructed epicardial activation maps at baseline and 6 months post-CRT. Positive VEU indicated LV uncoupling (delay) from the RV, whereas negative VEU indicated RV uncoupling (delay) from the LV. Difference in difference (change in VEU from baseline to 6 months post-CRT) is reported as the primary outcome.

  baseline and 6 months after device implantation

Secondary Outcomes (2)

• Change in 6-minute Walk Distance 6 Months Post CRT

  baseline and 6 months after device implantation

• Change in MLHFQ Total Score

  baseline and 6 months after device implantation

Study Arms (3)

aCRT Off

ACTIVE COMPARATOR

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

Device: Conventional Cardiac Resynchronization Therapy

aCRT On

EXPERIMENTAL

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

Device: Adaptive cardiac resynchronization therapy

Registry arm

NO INTERVENTION

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.

Interventions

Adaptive cardiac resynchronization therapy DEVICE

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.

Also known as: aCRT

aCRT On

Conventional Cardiac Resynchronization Therapy DEVICE

CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.

Also known as: CRT

aCRT Off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larisa Tereshchenko: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 34430943 RESULT

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Larisa Tereshchenko
• Organization: Cleveland Clinic, Lerner Research Institute

tereshl@ccf.org

2164442445

Study Officials

• Larisa Tereshchenko, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 7, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 20, 2025
• Results First Posted: November 28, 2023

Record last verified: 2025-03

Locations

US (1)