MODULA Modul 7 VRR: Correlation Between Ventricular Rate Regulation (VRR) and the Percentage of Biventricular Pacing in Cardiac Resynchronization Therapy (CRT) Patients With Atrial Fibrillation - Full Text View

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180414

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)	Phase IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
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

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

percentage of biventricular pacing

Secondary Outcome Measures:

correlation between VRR and the subjective quality of life
correlation between VRR and the symptoms caused by conducted atrial arrhythmias
correlation between VRR and physical ability (6 minute walk test, optional spiroergometry)

Estimated Enrollment:	40
Study Start Date:	August 2003
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180414

Locations

Germany
Klinikum Lüdenscheid / Kardiologie
Lüdenscheid, Germany, 58515

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Bernd Lemke, MD

Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany

More Information

Study ID Numbers:	Version vom 10.07.2003 BIS
Study First Received:	September 12, 2005
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00180414
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Guidant Corporation:

heart failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Quality of Life
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009