MODULA Modul 7 VRR

Not Applicable

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)

• Registration Number: NCT00180414
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-08-28
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2008-05-07
• Study Completion: 2008-05-07
• Results First Submitted: 2021-06-22
• Results First Submitted QC: 2022-03-02
• Results First Posted: 2022-03-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ventricular Rate Regulation feature ON	CRT devices with ventricular rate regulation [VRR] (CE labeled)	-
Ventricular Rate Regulation feature OFF	CRT devices with ventricular rate regulation [VRR] (CE labeled)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Biventricular Pacing	6 month	Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinikum Lüdenscheid / Kardiologie; 🇩🇪 Luedenscheid, Germany