Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Flinders Medical Centre, Bedford Park, South Australia, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject implanted or upgraded with a NG3 or NG4 CRT-D device connected with any manufacturer quadripolar LV lead based on BSC labeling for devices in specific geographies.
Subjects must be enrolled between 1 and 21 calendar days post CRT-D implantation procedure.
Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
Subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol

Exclusion criteria

Subject with documented life expectancy of less than 12 months
Subject currently on the active heart transplant list or has a current Left Ventricular Assist Device or other assist device (mechanical circulatory support device).
Subject who have had a pre-existing CRT device
Subject enrolled in any other concurrent clinical trial without prior written approval from BSC Clinical Trial Manager
Women of childbearing potential who are or might be pregnant at time of study enrolment
Any contra-indication to receive a CRT-D device per local guidelines

Treatment and study plan

Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Device

The optimization during the standard of care visits in the first 12 months following implantation

Primary outcomes

CRT Response Rate

Time frame: 12 months

The traditional outcome of interest when using the Clinical Composite Score (CCS) is the proportion of patients who improved. Improvement was defined as remaining alive and free of heart failure hospitalization while also demonstrating improvement in NYHA Class, patient Global Assessment, or both. Patients were considered worsened if they died, experienced a heart failure hospitalization, or had worsened NYHA Class or patient Global Assessment. Patients who neither improved nor worsened were classified as "no change."
Percentage of Post Market Clinical Follow Up Participants Without NG4 Pulse Generator Related Complications

Time frame: 36 months
Complication Free rate. PG-related Complication is defined as those detectable adverse events that resulted in:
- Death
- Serious injury
- Correction of PG failure requiring invasive intervention
- Permanent loss of PG device function. Permanent loss of device function is defined as any Pulse Generator (PG) that reverts to Safety Core or any PG rendered unable to deliver pacing or shocks Complications that are determined to be associated with the PG will be considered PGrelated complications (PG) and count against the PMCF endpoint. Complications related to the LV, RV, RA leads will not be counted against the PMCF endpoint.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

Acronym: SMART Registry

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Mar 9, 2017
Registry last updated: Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed