MODULA Modul 7 VRR

June 22, 2022 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Luedenscheid, Germany, 58515
        • Klinikum Lüdenscheid / Kardiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ventricular Rate Regulation feature ON
Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)
Active Comparator: Ventricular Rate Regulation feature OFF
Device: CRT devices with ventricular rate regulation [VRR] (CE labeled)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Biventricular Pacing
Time Frame: 6 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between VRR and the Subjective Quality of Life
Time Frame: 6 Month
Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups
6 Month
Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
Time Frame: 6 months
Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups
6 months
Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
Time Frame: 6 months
Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

Guidant Corporation

Investigators

  • Principal Investigator: Bernd Lemke, MD, Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2004

Primary Completion (Actual)

May 7, 2008

Study Completion (Actual)

May 7, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version vom 10.07.2003 BIS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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