Cardiac Resynchronization Therapy Efficacy Enhancements
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 71
- Locations
- 19
- Primary Endpoint
- Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
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).
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Percentage of Effective CRT Pacing During AF (Superiority Test)(Up to 4 months)