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
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
- 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.
- 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
- 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
- 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
- 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
- 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
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
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Larisa Tereshchenko, MD, PhD||Oregon Health and Science University|