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

Atrial Fibrillation Clinical Trial

— CRTee  

Official title:

Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02222818
• Other study ID #: CRTee
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2014
• Last updated: April 6, 2015
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: Rachael K Rose, BS, MBA
• Phone: 763-526-2332
• Email: medtroniccrmtrials[@]medtronic.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Human Research Ethics CommitteeSlovakia: State Institute for Drug ControlSaudi Arabia: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: Ministry of HealthHungary: Authority for Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Conducted AF Response Plus (CAFRPlus)

• Conducted AF Response (CAFR)

Locations

Country	Name	City	State
United States	Medtronic, Inc	Mounds View	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of effective CRT	Percentage of effective CRT pacing during AF	Randomization, up to 4 months	No