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Adaptive CRT Effect on Electrical Dyssynchrony | Clinical Trials | Clareo Health

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Adaptive CRT Effect on Electrical Dyssynchrony

NCT02543281•Larisa Tereshchenko

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

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

September 1, 2021

Completion Date

September 1, 2021

Last Updated

March 20, 2025

Enrollment

ACTUAL participants

Conditions

CardiomyopathyHeart FailureLeft Bundle Branch Block

Interventions

Adaptive cardiac resynchronization therapy

DEVICE

Conventional Cardiac Resynchronization Therapy

DEVICE

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adaptive CRT Effect on Electrical Dyssynchrony

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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