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REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT) (REINVENT)

Primary Purpose

Left Ventricular Ejection Fraction, Heart Failure (HF), Left Bundle-Branch Block

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LB-CRT
BIV-CRT
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Left Ventricular Ejection Fraction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Stated willingness to comply with all study procedures and availability for the duration of the study Male or female aged ≥18 years Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads. NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic LVEF >35% by clinically obtained echocardiogram overread by the study core-lab Demonstration of adequate echocardiographic images to allow for assessment of endpoints On a stable guideline directed HF medical regimen For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Exclusion Criteria: Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study Treatment with another investigational drug or other intervention within 3 months Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation) Significant structural heart [including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)] Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg) Oxygen dependent chronic lung disease Prolonged episodes of AF (>3 days or an AF burden >10%) within the preceding 3 months Presence of cardiac pacemaker or implantable cardioverter defibrillator Prior mechanical tricuspid valve replacement Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus Known allergic reactions to components of the pacemaker or leads Febrile illness within 3 days of trial enrollment Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Control Participant Exclusion Criteria: same

Sites / Locations

  • Duke University Medical Center
  • Inova Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group

BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group

Outcomes

Primary Outcome Measures

Change in myocardial performance index (MPI) as compared to Baseline
Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
March 27, 2023
Sponsor
Inova Health Care Services
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT05652218
Brief Title
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Acronym
REINVENT
Official Title
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT), a Phase I Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide levels among patients with symptomatic HF, LVEF > 35%, and LBBB.
Detailed Description
This pilot study will be a multicenter randomized controlled trial involving 20 medically stable outpatients with heart failure (HF), preserved or mildly reduced LVEF (>35%), and LBBB. Patients will undergo implantation of a Medtronic Percepta CRT-P with an atrial lead, left bundle branch area pacing (LBBap) lead, and a LV lead. They will then be randomly allocated in a 1:1 fashion to usual care plus LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1) or usual care plus BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Ejection Fraction, Heart Failure (HF), Left Bundle-Branch Block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single arm crossover study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
LB-CRT - Left Bundle Cardiac Resynchronization Therapy, Participants will spend 3 months in this group
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
BiV-CRT - Biventricular Pacing Cardiac Resynchronization Therapy. Participants will spend 3 months in this group
Intervention Type
Device
Intervention Name(s)
LB-CRT
Intervention Description
LB-CRT (DDD 60-130, LV lead turned off) (active intervention #1)
Intervention Type
Device
Intervention Name(s)
BIV-CRT
Intervention Description
BIV-CRT (DDD 60- 130, LV lead turned on) (active intervention #2).
Primary Outcome Measure Information:
Title
Change in myocardial performance index (MPI) as compared to Baseline
Description
Myocardial performance index (MPI), a global measure of cardiac performance is defined using tissue Doppler imaging.
Time Frame
Baseline and 3 month treatment period after each pacing mode

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Stated willingness to comply with all study procedures and availability for the duration of the study Male or female aged ≥18 years Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads. NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic LVEF >35% by clinically obtained echocardiogram overread by the study core-lab Demonstration of adequate echocardiographic images to allow for assessment of endpoints On a stable guideline directed HF medical regimen For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Exclusion Criteria: Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study Treatment with another investigational drug or other intervention within 3 months Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation) Significant structural heart [including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)] Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg) Oxygen dependent chronic lung disease Prolonged episodes of AF (>3 days or an AF burden >10%) within the preceding 3 months Presence of cardiac pacemaker or implantable cardioverter defibrillator Prior mechanical tricuspid valve replacement Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus Known allergic reactions to components of the pacemaker or leads Febrile illness within 3 days of trial enrollment Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Control Participant Exclusion Criteria: same
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Plummer, BSN
Phone
703.776.3567
Email
tracy.plummer@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
Edwinia Battle, BSN
Phone
703.776.3067
Email
edwinia.battle@inova.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Atwater, MD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Friedman, MD
Phone
315-243-6590
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Plummer, BSN
Email
tracy.plumer@inova.org
First Name & Middle Initial & Last Name & Degree
Brett Atwater, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)

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