Adaptive CRT Effect on Electrical Dyssynchrony

NCT ID: NCT02543281

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2021-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

aCRT Off

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

Group Type: ACTIVE_COMPARATOR

Conventional Cardiac Resynchronization Therapy

Intervention Type: DEVICE

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

aCRT On

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

Group Type: EXPERIMENTAL

Adaptive cardiac resynchronization therapy

Intervention Type: 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.

Registry arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Conventional Cardiac Resynchronization Therapy

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

Intervention Type: DEVICE

Other Intervention Names

aCRT; CRT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Larisa Tereshchenko

OTHER

Sponsor Role: lead

Responsible Party

Larisa Tereshchenko

Assistant Professor, Department of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Larisa Tereshchenko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34430943 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-11299

Identifier Type: -

Identifier Source: org_study_id