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Adaptive CRT Effect on Electrical Dyssynchrony (aCRT-ELSYNC)

Primary Purpose

Cardiomyopathy, Heart Failure, Left Bundle Branch Block

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adaptive cardiac resynchronization therapy

Conventional Cardiac Resynchronization Therapy

About this trial

This is an interventional treatment trial for Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

Sites / Locations

Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

aCRT Off

aCRT On

Arm Description

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

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

Outcomes

Primary Outcome Measures

Regression slope of Electrical dyssynchrony index

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.

Difference in regression slopes of SAI QRST against EDI vs. QRS duration against EDI

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

Regression slope of surface ECG and intracardiac spatial QRS-T angle and VCG QRS and T loops morphology

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

Clinical Composite Score

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

Reverse electrical remodeling

Shortened duration of non-paced QRS complex 6 months post-CRT greater than or equal 10 ms

regression slope of PeRV1 interval

PeRV1 interval measured 6 months post- CRT, regressed against PeRV1 interval measured prior CRT

Full Information

NCT ID

NCT02543281

First Posted

September 1, 2015

Last Updated

January 11, 2022

Sponsor

Larisa Tereshchenko

1. Study Identification

Unique Protocol Identification Number

NCT02543281

Brief Title

Adaptive CRT Effect on Electrical Dyssynchrony

Acronym

aCRT-ELSYNC

Official Title

Adaptive CRT Effect on Electrical Dyssynchrony

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Larisa Tereshchenko

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiomyopathy, Heart Failure, Left Bundle Branch Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

aCRT Off

Arm Type

Active Comparator

Arm Description

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

Arm Title

aCRT On

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Adaptive cardiac resynchronization therapy

Other Intervention Name(s)

aCRT

Intervention Description

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

Intervention Name(s)

Conventional Cardiac Resynchronization Therapy

Other Intervention Name(s)

CRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Regression slope of Electrical dyssynchrony index

Description

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.

Time Frame

6 months after device implantation

Title

Difference in regression slopes of SAI QRST against EDI vs. QRS duration against EDI

Description

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

Time Frame

6 months after device implantation

Secondary Outcome Measure Information:

Title

Regression slope of surface ECG and intracardiac spatial QRS-T angle and VCG QRS and T loops morphology

Description

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

Time Frame

6 months after device implantation

Title

Clinical Composite Score

Description

Time Frame

6 months after device implantation

Title

Reverse electrical remodeling

Description

Shortened duration of non-paced QRS complex 6 months post-CRT greater than or equal 10 ms

Time Frame

6 months after device implantation

Title

regression slope of PeRV1 interval

Description

PeRV1 interval measured 6 months post- CRT, regressed against PeRV1 interval measured prior CRT

Time Frame

6 months after device implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Larisa Tereshchenko, MD, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34430943

Citation

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.

Results Reference

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