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Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222818
First Posted: August 21, 2014
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

Condition Intervention
Atrial Fibrillation Device: Conducted AF Response (CAFR) Device: Conducted AF Response Plus (CAFRPlus)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy Efficacy Enhancements

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Percentage of Effective CRT Pacing During AF (Non-inferiority Test) [ Time Frame: Up to 4 months ]
    The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).


Secondary Outcome Measures:
  • Percentage of Effective CRT Pacing During AF (Superiority Test) [ Time Frame: Up to 4 months ]
    The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).


Enrollment: 71
Study Start Date: October 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A: CAFR first
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Device: Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Device: Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
Group B: CAFRPlus first
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Device: Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Device: Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.

Detailed Description:

The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is willing to sign and date the study patient Informed Consent form.
  • Subject is at least 18 years of age (or older, if required by local law).
  • Subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
  • Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 days prior to enrollment.
  • Subject has history of AF burden, of at least 6 days of at least 4 hours of AF over any 4 week period within the last 90 days as documented in device diagnostic data OR if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high AF burden.
  • Subject has demonstrated history of being able to complete Left Ventricular Capture Management (LVCM) documented in device data.
  • Subject has a documented % V pacing during AF of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.

Exclusion Criteria:

  • Subject has undergone AV node ablation for treatment of AF.
  • Subject has complete or 3rd degree AV block.
  • Subject has had an MI within 30 days.
  • Subject has medical conditions that limit study participation (per physician discretion).
  • Subject is enrolled in one or more concurrent studies that could confound the study results as determined by Medtronic.
  • Subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
  • Subject is pregnant (in the US, all women of child-bearing potential must undergo a pregnancy test within seven days prior to CRTee download).
  • Subject meets the exclusion criteria required by local law.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222818


Locations
United States, Florida
Cardiac Arrythmia Services
Boca Raton, Florida, United States
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States
United States, Minnesota
North Memorial Heart and Vascular
Minneapolis, Minnesota, United States
CentraCare
St. Cloud, Minnesota, United States
United States, North Carolina
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
United States, Ohio
Mount Carmel
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma Heart
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Berks Cardiology
Reading, Pennsylvania, United States
United States, Texas
Texas Cardiac Arrhythmia Services
Austin, Texas, United States, 78705
United States, Washington
Kootenai Heart Clinics
Spokane, Washington, United States
Hungary
Magyar Honvédség Honvédkorház
Budapest, Hungary
Italy
Policlinico Universitario Agostino Gemelli
Roma, Italy
Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
Seriate, Italy
Azienda Ospedaliera Cardinale Panico
Tricase, Italy
Saudi Arabia
Prince Sultan Cardiac Center
Riyadh, Saudi Arabia
Slovakia
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Kosice, Slovakia
South Africa
Mediclinic Panorama
Cape Town, South Africa
United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: Suneet Mittal, MD Valley Health System
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02222818     History of Changes
Other Study ID Numbers: CRTee
First Submitted: August 19, 2014
First Posted: August 21, 2014
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes