Septal Mapping And Resynchronisation Therapy- (SMART) Study

NCT04595305 | Completed

• 1 other identifier: ABT-CIP-10291
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Normal heart function involves rhythmic contraction of all four chambers of the heart and this rhythm is maintained by the electrical wiring (conduction system) of the heart. Abnormality in this system results in either very slow or very fast heart rates leading to insufficient blood supply to the body due to inefficient pumping of the heart. cardiac resynchronization therapy pacemaker and cardiac resynchronization therapy defibrillator devices are used to synchronise heart function. The purpose of this study is not only to determine the pattern of electrical wiring of the heart and identify the variations seen in individuals with heart failure, but also, to explore the benefits of different types of pacing using CRT devices.

Conditions

Cardiac Resynchronization Therapy; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Quantification of activation times (ms) of the RV and LV septum

  Different pacing configurations such as LV-only pacing, biventricular pacing, and multipoint pacing will be used to quantify LV and RV septal activation time (ms).

  During implant procedure

Secondary Outcomes (1)

• Quantification of the correlation coefficient relating changes in end-systolic volume (%) to the following variables: septal activation time (ms), septal scarring (% area), and ECG QRS duration (ms).

  12 months post-implant

Study Arms (1)

Treatment Arm - Standard of Care

OTHER

Implantation of CRT-P or CRT-D for a clinical indication as per standard of care.

Device: Cardiac resynchronization therapy by CRT-P or CRT-D implantation

Interventions

Cardiac resynchronization therapy by CRT-P or CRT-D implantation DEVICE

Clinically indicated implantation of a CRT-P or CRT-D device as per standard of care

Also known as: Cardiac resynchronization therapy

Treatment Arm - Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are 18 years of age or older, or of legal age to give informed consent specific to state and national law
• Subject must provide written informed consent prior to any clinical investigation related procedure
• Subjects who are undergoing implantation of an Abbott CRT-P or CRT-D device under standard indications
• Subjects are treated with optimal pharmacological therapy (as determined by the site principle investigator) for a minimum 4 weeks prior to procedure
• ECG showing Sinus Rhythm (SR)
• LBBB morphology with QRS duration \>130ms
• Subject should be willing and able to comply with the prescribed follow-up schedule of evaluations.
• Female subjects of child-bearing potential should have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

You may not qualify if:

• Subjects with a life expectancy less than the duration of the study
• Subjects with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
• Subjects with mechanical tricuspid or aortic heart valves
• Inaccessibility for follow-up at the study centre
• Unwillingness or inability to provide written informed consent
• Enrollment in, or intention to participate in, another clinical study during the course of this study excluding a registry
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Medical Australia Pty Ltd

Macquarie Park, New South Wales, 2113, Australia

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• David O'Donnell, MD, FRACP

  Fundacion GenesisCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: October 20, 2020
• Study Start: September 16, 2019
• Primary Completion: August 5, 2021
• Study Completion: August 23, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)