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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)
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180414
First received: September 12, 2005
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  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 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:

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00180414     History of Changes
Other Study ID Numbers: Version vom 10.07.2003 BIS
Study First Received: September 12, 2005
Last Updated: April 22, 2009
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
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013