Adaptive CRT Effect on Electrical Dyssynchrony (aCRT-ELSYNC)

• ClinicalTrials.gov Identifier: NCT02543281
• Recruitment Status: Active, not recruiting
• First Posted: September 7, 2015
• Last Update Posted: June 14, 2019
• Sponsor: Larisa Tereshchenko
• Information provided by (Responsible Party): Larisa Tereshchenko, Oregon Health and Science University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Larisa Tereshchenko

Investigators

• Principal Investigator: Larisa Tereshchenko, MD, PhD; Oregon Health and Science University

More 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
• Last Update Posted: June 14, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Cardiomyopathies; Bundle-Branch Block; Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes