MODULA Modul 7 VRR

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00180414
• Other study ID #: Version vom 10.07.2003 BIS
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2004
• Est. completion date: May 7, 2008

Study information

• Verified date: June 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 7, 2008
• Est. primary completion date: May 7, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Lüdenscheid / Kardiologie	Luedenscheid

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Guidant Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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