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CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation

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Medtronic

Status and phase

Terminated
Phase 4

Conditions

Atrial Fibrillation
Heart Failure
Sudden Cardiac Death

Treatments

Device: Conducted AF-Response Algorithm (CAFR) On
Device: Conducted AF-Response Algorithm (CAFR) Off

Study type

Interventional

Funder types

Industry

Identifiers

NCT00170313
CEN_G_CA_6

Details and patient eligibility

About

The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response

Exclusion criteria

  • Medical reasons that are adverse to participation in the study and compliance by the patient
  • Patients who are enrolled in another study or plan to be enrolled into another study
  • Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Conducted AF-Response Algorithm (CAFR) On
Experimental group
Description:
CAFR: On * Level medium * Max. Rate: 110ppm VSR: Off
Treatment:
Device: Conducted AF-Response Algorithm (CAFR) On
Conducted AF-Response Algorithm (CAFR) Off
Active Comparator group
Description:
CAFR: Off VSR: Off
Treatment:
Device: Conducted AF-Response Algorithm (CAFR) Off

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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