Cardiac Resynchronization Therapy Efficacy Enhancements

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02222818

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

71

Starts

2014-10-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cardiac Arrythmia Services — Boca Raton, Florida, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• North Memorial Heart and Vascular — Minneapolis, Minnesota, United States
• CentraCare — Saint Cloud, Minnesota, United States
• North Carolina Heart and Vascular — Raleigh, North Carolina, United States
• Mount Carmel — Columbus, Ohio, United States
• Oklahoma Heart — Oklahoma City, Oklahoma, United States
• Berks Cardiology — Reading, Pennsylvania, United States
• Texas Cardiac Arrhythmia Services — Austin, Texas, United States
• Kootenai Heart Clinics — Spokane, Washington, United States
• Magyar Honvédség Honvédkorház — Budapest, Hungary
• Policlinico Universitario Agostino Gemelli — Roma, Italy
• Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini — Seriate, Italy
• Azienda Ospedaliera Cardinale Panico — Tricase, Italy
• Prince Sultan Cardiac Center — Riyadh, Saudi Arabia
• Vychodoslovensky ustav srdcovych a cievnych chorob, a.s. — Košice, Slovakia
• Mediclinic Panorama — Cape Town, South Africa
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.