Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Adaptive CRT Effect on Electrical Dyssynchrony (aCRT-ELSYNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02543281
Recruitment Status : Active, not recruiting
First Posted : September 7, 2015
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Heart Failure Left Bundle Branch Block Device: Adaptive cardiac resynchronization therapy Device: Conventional Cardiac Resynchronization Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Adaptive CRT Effect on Electrical Dyssynchrony
Study Start Date : April 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: aCRT Off
The adaptive CRT algorithm will be turned off for the CRT device implanted in the patients in this arm.
Device: Conventional Cardiac Resynchronization Therapy
CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
Other Name: CRT

Experimental: aCRT On
The adaptive CRT algorithm will be turned on for the CRT device implanted in the patients in this arm.
Device: 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.
Other Name: aCRT




Primary Outcome Measures :
  1. Regression slope of Electrical dyssynchrony index [ Time Frame: 6 months after device implantation ]
    Regression slope of Electrical Dyssynchrony Index values measured on epicardial activation map 6 months post-CRT, regressed against Electrical Dyssynchrony Index values measured by ECGi prior CRT.

  2. Difference in regression slopes of SAI QRST against EDI vs. QRS duration against EDI [ Time Frame: 6 months after device implantation ]
    Difference in regression slopes of SAI QRST against Electrical Dyssynchrony Index vs. QRS duration against Electrical Dyssynchrony Index prior CRT and 6 months post-CRT


Secondary Outcome Measures :
  1. Regression slope of surface ECG and intracardiac spatial QRS-T angle and VCG QRS and T loops morphology [ Time Frame: 6 months after device implantation ]
    Surface ECG and intracardiac spatial QRS-T angle and QRS & T loops morphological characteristics measured 6 months post-CRT regressed against the same measures prior CRT

  2. Clinical Composite Score [ Time Frame: 6 months after device implantation ]
    End-point adjudication committee will adjudicate all available information and decide whether patient (1) improved; (2) worsened; (3) not changed, based on: 6-minute walk distance change, NYHA class change, heart failure hospitalization, death, CRT removal (or turned OFF), MLHFQ and SF-36 score change, LVEF / LVESV change on echocardiogram

  3. Reverse electrical remodeling [ Time Frame: 6 months after device implantation ]
    Shortened duration of non-paced QRS complex 6 months post-CRT greater than or equal 10 ms

  4. regression slope of PeRV1 interval [ Time Frame: 6 months after device implantation ]
    PeRV1 interval measured 6 months post- CRT, regressed against PeRV1 interval measured prior CRT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543281


Locations
Layout table for location information
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Larisa Tereshchenko
Investigators
Layout table for investigator information
Principal Investigator: Larisa Tereshchenko, MD, PhD Oregon Health and Science University

Layout table for additonal information
Responsible Party: Larisa Tereshchenko, Assistant Professor, Department of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02543281    
Other Study ID Numbers: IRB-11299
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Bundle-Branch Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes