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AdaptResponse Clinical Trial

NCT02205359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3797

Last updated 2023-11-29

Study results available
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Summary

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

Conditions

  • Heart Failure With Left Bundle Branch Block

Interventions

DEVICE

aCRT ON

CRT device with AdaptivCRT enabled (AdaptivBiV and LV)

DEVICE

aCRT OFF

CRT device with AdaptivCRT disabled

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Bruce Wilkoff, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2022-11-02
Completion
2022-11-02

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Saudi Arabia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT02205359 on ClinicalTrials.gov