Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

NCT ID: NCT01475175

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-03-31

Brief Summary

The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.

Detailed Description

Adaptive CRT is an implantable heart failure device feature that attempts to optimize CRT without echocardiographic testing.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRT pacing at rest and during exercise

Rest and sub-maximal exercise

Group Type: EXPERIMENTAL

CRT pacing at rest and during exercise

Intervention Type: DEVICE

CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise

Interventions

CRT pacing at rest and during exercise

CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is age 18 or greater
• Subject is willing to sign and date the study Informed Consent form
• Subject has been implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months from the date of study enrollment

Exclusion Criteria

• Subject has a history of persistent or permanent AF for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted.
• Subject has atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy at the time of enrollment.
• Subject's resting heart rate at the time of enrollment exceeds 90 bpm.
• Subject had CRT system implanted for more than 7 months from the date of the study enrollment
• Subject has complete AV block.
• Subject had previous mechanical valve surgeries.
• Subject has congenital heart disease.
• Subject has contraindication for an exercise test.
• Subject is unable to perform a sub-maximal exercise test.
• It is not possible to acquire technically acceptable echocardiographic images.
• Subject has medical conditions that would limit study participation.
• Subject is pregnant (all women of child-bearing potential must undergo a pregnancy test within seven days prior to the study visit).
• Subject is enrolled in the Adaptive CRT study
• Subject is enrolled in concurrent studies which could confound the results of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AdOPT CRT/aCRT Study Team

Role: STUDY_CHAIR

Medtronic

Locations

Linz, , Austria

Genk, , Belgium

Leuven, , Belgium

Aarhus, , Denmark

Lüdenscheid, , Germany

Nijmegen, , Netherlands

Oslo, , Norway

Countries

Austria; Belgium; Denmark; Germany; Netherlands; Norway

Other Identifiers

AdOPT CRT Sub Study

Identifier Type: -

Identifier Source: org_study_id