NCT03936608

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

April 30, 2019

Results QC Date

August 5, 2020

Last Update Submit

November 11, 2020

Conditions

Systolic Heart FailureCardiac Resynchronization TherapyElectrocardiography

Keywords

CRT Programming

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome is Echocardiographic LV End-systolic Volume.

    LV end-systolic volume is a reliable surrogate for clinical outcomes in clinical heart failure trials.

    3-12 months

Study Arms (2)

Individualized RV-LV Pacing Offset

EXPERIMENTAL
Device: Programming individualized RV-LV pacing offset to optimize ECG

No RV-LV Pacing Offset

ACTIVE COMPARATOR
Device: Nominally programming CRT device without RV-LV offset

Interventions

Programming individualized RV-LV pacing offset to optimize ECGDEVICE

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.

Individualized RV-LV Pacing Offset
Nominally programming CRT device without RV-LV offsetDEVICE

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.

No RV-LV Pacing Offset

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Amit Noheria
Organization
The University of Kansas
amit.noheria@gmail.com
9135889757

Study Officials

  • Amit Noheria, MBBS, SM

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Sandeep Sodhi, MD

    Washington University School of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

April 22, 2019

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

December 3, 2020

Results First Posted

December 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)