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Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

NCT03089281 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2022-04-05

Study results available
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Summary

The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

Conditions

Interventions

DEVICE

CRT-D

Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing. All enrolled subjects with implanted BSC X4 CRT-D system and identified with an RV-LV delay of ≥70ms were 1:1 randomized. Randomization occurred in the electronic data capturing system.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Michael R. Gold, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2020-09-15
Completion
2020-09-15
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03089281 on ClinicalTrials.gov