MODULA Modul 7 VRR

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MODULA-Study: Modul 7 VRR: 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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventricular Rate Regulation feature ON<br> | Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)<br> <br> |
| Active Comparator: Ventricular Rate Regulation feature OFF<br> | Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Biventricular Pacing | Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between VRR and the Subjective Quality of Life | Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups | 6 Month | 
| Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias | Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups | 6 months | 
| Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry) | Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure