Recruiting

Resynchronization Devices

Sponsor:

Allina Health System

Code:

NCT04083690

Conditions

Heart Failure, Systolic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Study Details

Brief summary:

Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.

Conditions

Heart Failure, Systolic

Study ID

NCT04083690

Start date

Oct 11, 2019

Status verified date

Jun, 2022

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Oct 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
2. Age greater than or equal 18 years
3. Pre-CRT EF less than or equal 40%
4. Patients will be receiving or have received a first-time CRT device for standard clinical indications within \~2 months of study enrollment
5. Adequate echocardiographic images for LV EF and LV ESV determination
6. On optimal medical therapy

Exclusion Criteria:

1. Patients who are pregnant or may become pregnant
2. Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
3. Patient has a His Bundle pacing lead
4. Patient has right bundle branch block (RBBB)
5. Patient is enrolled in concurrent research study that would potentially confound the results of this study
6. Premature ventricular contraction (PVC) burden greater than or equal to 10%

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard CRT Programming, then ECG CRT Optimization

The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months

experimental: ECG CRT Optimization

The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.

Interventions

Reprogramming of CRT Device Settings to Optimal Electrical Synchrony

Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.

Primary outcome measure

  • Change in left ventricular size [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Minneapolis Heart Institute (Abbott Northwestern Hospital)

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Alan J Bank, MD

United Heart & Vascular Clinic

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Alan J Bank, MD

More Information

Sponsor

Allina Health System

Last update posted

Jun 9, 2022

Last verified

Jun, 2022

Keywords

  • Cardiac Resynchronization Therapy
  • Pacing
  • Echocardiography
  • Electrocardiography
  • Optimization
  • Heart Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allina Health System on 2022-06-09.