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

This study has been terminated.
(low enrolment rate)
Information provided by:
Guidant Corporation Identifier:
First received: September 12, 2005
Last updated: March 9, 2015
Last verified: March 2015
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

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
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180414

Klinikum Lüdenscheid / Kardiologie
Luedenscheid, Germany, 58515
Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Bernd Lemke, MD Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
  More Information

No publications provided Identifier: NCT00180414     History of Changes
Other Study ID Numbers: Version vom 10.07.2003 BIS 
Study First Received: September 12, 2005
Last Updated: March 9, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Guidant Corporation:
heart failure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on February 08, 2016