Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03936608 |
Other study ID # |
201901208 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 22, 2019 |
Est. completion date |
November 21, 2019 |
Study information
Verified date |
November 2020 |
Source |
Washington University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.