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

NCT01475175 | Terminated Results

• 1 other identifier: AdOPT CRT Sub Study
• Study Type: interventional
• Target: 12
• Locations: 6 countries
• Sites: 7

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Stroke Volume at Rest

  Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.

  Test day visit (within 14 days of enrollment)

• Stroke Volume During Atrial Pacing.

  Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.

  Test day visit (within 14 days of enrollment)

• Stroke Volume During Sub-maximal Exercise.

  Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.

  Test day visit (within 14 days of enrollment)

Secondary Outcomes (6)

• Cardiac Function With aCRT Settings at Rest

  Test day visit (within 14 days of enrollment)

• Cardiac Function With Nominal Settings at Rest.

  Test day visit (within 14 days of enrollment)

• Cardiac Function With aCRT Settings During Sub-maximal Exercise.

  Test day visit (within 14 days of enrollment)

• Cardiac Function With Nominal Settings During Sub-maximal Exercise.

  Test day visit (within 14 days of enrollment)

• Electrical Conduction at Rest.

  Test day visit (within 14 days of enrollment)

Study Arms (1)

CRT pacing at rest and during exercise

EXPERIMENTAL

Rest and sub-maximal exercise

Device: CRT pacing at rest and during exercise

Interventions

CRT pacing at rest and during exercise DEVICE

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

CRT pacing at rest and during exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

Unknown Facility

Linz, Austria

Location

Unknown Facility

Genk, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Aarhus, Denmark

Location

Unknown Facility

Lüdenscheid, Germany

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Oslo, Norway

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Planned interim evaluation of sample size calculation assumptions showed variability higher than assumed and planned sample size underpowered for assumed difference. Objectives were not analyzed.

Results Point of Contact

• Title: AdOpt CRT Clinical Research Specialist
• Organization: Medtronic CRDM

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• AdOPT CRT/aCRT Study Team

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 5, 2019
• Results First Posted: October 12, 2012

Record last verified: 2019-06

Locations

AU (1); BE (2); DE (1); NL (1); NO (1); DK (1)