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ECG for Programming in CRT (EPIC)

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: NCT03936608
Recruitment Status : Terminated (PI left Washington University)
First Posted : May 3, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Patients with heart failure and left bundle branch block benefit from Cardiac Resynchronization Therapy (CRT) that delivers pacing from right ventricle (RV) and left ventricle (LV) synchronously, resulting in electrical ventricular resynchrony followed by revere structural cardiac remodeling and thereby reduced heart failure symptoms, hospitalizations and death. It is not known if programming an individually optimized RV-LV pacing offset to maximize electrical resynchrony can improve benefit from CRT.

The proposed study is a randomized controlled trial in patients undergoing implant of a CRT pacemaker/defibrillator device for clinical indications to evaluate benefit of RV-LV offset programming using electrocardiogram (ECG) vs. standard nominal CRT programming without RV-LV offset. Patients receiving CRT devices will be randomized to either (A) active intervention of programming RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV- LV offset. The patients will be followed to evaluate change in echocardiogram, quality of life, functional evaluation and a blood marker for heart failure.


Condition or disease Intervention/treatment Phase
Systolic Heart Failure Cardiac Resynchronization Therapy Electrocardiography Device: Programming individualized RV-LV pacing offset to optimize ECG Device: Nominally programming CRT device without RV-LV offset Not Applicable

Detailed Description:

Once the eligibility for the study is determined and patient has consented for participation, all study participants will undergo a baseline evaluation (within 6 weeks prior to 2 weeks after CRT device implant/upgrade). Echocardiogram, quality-of-life questionnaire, 6-minute hall walk, blood test, vital signs, ECGs, device interrogation and baseline demographic and medical history including chart review will be obtained. After CRT device implant/upgrade, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs and echocardiography. A randomized assignment using a random allocation table in REDCap will be used to program patients to (A) intervention or (B) control RV-LV offset setting. Patients will return for study follow-up between 3-12 months. Follow-up evaluations will include echocardiography, quality-of-life questionnaire, 6-minute hall walk test, blood test, vital signs, ECGs, device interrogation, and follow-up medical history including chart review. The patients will continue to be in extended follow-up through review of their medical charts till the end of the study (12 months from date of CRT implant/upgrade of the the last study participant).

Treatment and control arms: All study patients will receive standard of care clinically indicated medical and device therapy per their treating physicians. After implant of a clinically indicated CRT device or upgrade of a preexisting pacemaker or defibrillator device to CRT system, participants will be randomized 1:1 to treatment arms (A) active intervention of programming individualized RV-LV pacing offset to optimize ECG or to (B) active control of nominally programming CRT device without RV-LV offset. Of note, both intervention and control treatment are active FDA-approved CRT therapies and no investigational device or programming will be used, and no clinically indicated treatment will be withheld from any patient. At any time, if in the judgment of the patient's treating physicians or the research team, any treatment including CRT programming different from the study protocol is necessitated for clinical reasons, the appropriate clinically indicated changes will be made. At the end of the study, if the participant is clinically doing well and the programmed CRT settings are deemed clinically appropriate they will be retained, else the CRT programming may be changed as per standard of care.

Enrolled participants who have a failed or unsatisfactory LV lead implant will not be randomized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrocardiogram for Programming in Cardiac Resynchronization Therapy
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : November 21, 2019
Actual Study Completion Date : November 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Individualized RV-LV Pacing Offset Device: Programming individualized RV-LV pacing offset to optimize ECG
After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.

Active Comparator: No RV-LV Pacing Offset Device: Nominally programming CRT device without RV-LV offset
After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.




Primary Outcome Measures :
  1. Reverse cardiac remodeling [ Time Frame: 3-12 months ]
    LV end-systolic volume on echocardiography


Secondary Outcome Measures :
  1. Kansas City Cardiomyopathy Questionnaire-12 [ Time Frame: 3-12 months ]
    KCCQ-12 is a self-administered instrument to measure health-related quality of life for heart failure. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Scores are scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.

  2. Functional performance [ Time Frame: 3-12 months ]
    6-minute hall walk test

  3. Serum N-terminal pro-brain natriuretic peptide [ Time Frame: 3-12 months ]
    Serum NT pro-BNP level is a prognostic biomarker for heart failure.


Other Outcome Measures:
  1. Reverse cardiac remodeling in patients with absolute optimal RV-LV offset ≥40 ms [ Time Frame: 3-12 months ]
    LV end-systolic volume on echocardiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥18 years of age who are able to give consent.
  • Diagnosis of systolic heart failure.
  • Planned to undergo new CRT device implant (or upgrade of preexisting pacemaker or defibrillator device to CRT system) for standard clinical indications.
  • Expected to have over 95% heart beats resynchronized with CRT (absence of competing arrhythmias or plans to not immediately activate CRT therapy).

Exclusion Criteria:

  • Unable to comply with the study follow-up.
  • Life expectancy ≤1 year.

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): NCT03936608


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Amit Noheria, MBBS, SM Washington University School of Medicine
Study Director: Sandeep Sodhi, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03936608    
Other Study ID Numbers: 201901208
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Washington University School of Medicine:
CRT Programming
Additional relevant MeSH terms:
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Heart Failure, Systolic
Heart Failure
Heart Diseases
Cardiovascular Diseases