Evaluate the Amount of Effective Cardiac Resynchronization Therapy (CRT) Pacing During AF (CRTee)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT02222818
First received: August 19, 2014
Last updated: August 20, 2014
Last verified: August 2014
  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 Plus (CAFRPlus)
Device: Conducted AF Response (CAFR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Percentage of effective CRT [ Time Frame: Randomization, up to 4 months ] [ Designated as safety issue: No ]
    Percentage of effective CRT pacing during AF


Estimated Enrollment: 75
Study Start Date: September 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conducted AF Response (CAFR) Device: Conducted AF Response (CAFR)
Experimental: Conducted AF Response Plus (CAFRPlus) Device: Conducted AF Response Plus (CAFRPlus)

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 20 centers located in the United States, Europe and Middle East and Africa (MEA).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02222818

Contacts
Contact: Rachael K Rose, BS, MBA 763-526-2332 medtroniccrmtrials@medtronic.com

Locations
United States, Minnesota
Medtronic, Inc Not yet recruiting
Mounds View, Minnesota, United States, 55118
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Suneet Mittal, MD Valley Health System
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT02222818     History of Changes
Other Study ID Numbers: CRTee
Study First Received: August 19, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
South Africa: Human Research Ethics Committee
Slovakia: State Institute for Drug Control
Saudi Arabia: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: Ministry of Health
Hungary: Authority for Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014