MODULA Modul 7 VRR

Boston Scientific

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180414

Version vom 10.07.2003 BIS

Details and patient eligibility

About

This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.

Full description

To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CRT system with the VRR algorithm
• Patients with permanent atrial fibrillation
• Occasional conducted atrial fibrillation resulting in ventricular rates > 70 beats per minute (bpm)
• QRS complex > 120 ms

Exclusion criteria

• Patients with third degree atrioventricular (AV) block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Ventricular Rate Regulation feature ON

Experimental group

Treatment:

Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)

Ventricular Rate Regulation feature OFF

Active Comparator group

Treatment:

Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)