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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

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ClinicalTrials.gov Identifier: NCT00180414
Recruitment Status : Terminated (low enrolment rate)
First Posted : September 16, 2005
Last Update Posted : February 23, 2017
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Study Description
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: CRT devices with ventricular rate regulation [VRR] (CE labeled) Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : August 2003
Primary Completion Date : May 2008
Study Completion Date : May 2008

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Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. percentage of biventricular pacing

Secondary Outcome Measures :
  1. correlation between VRR and the subjective quality of life
  2. correlation between VRR and the symptoms caused by conducted atrial arrhythmias
  3. correlation between VRR and physical ability (6 minute walk test, optional spiroergometry)

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180414


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

ClinicalTrials.gov Identifier: NCT00180414     History of Changes
Other Study ID Numbers: Version vom 10.07.2003 BIS
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Boston Scientific Corporation:
heart failure

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes