Back to resultsMODULA Modul 7 VRR
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CRT devices with ventricular rate regulation [VRR] (CE labeled)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring heart failure
Eligibility 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
Sites / Locations
- Klinikum Lüdenscheid / Kardiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ventricular Rate Regulation feature ON
Ventricular Rate Regulation feature OFF
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Biventricular Pacing
Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
Secondary Outcome Measures
Correlation Between VRR and the Subjective Quality of Life
Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups
Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups
Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry
Full Information
NCT ID
NCT00180414
First Posted
September 12, 2005
Last Updated
June 22, 2022
Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00180414
Brief Title
MODULA Modul 7 VRR
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 Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
low enrolment rate
Study Start Date
August 28, 2004 (Actual)
Primary Completion Date
May 7, 2008 (Actual)
Study Completion Date
May 7, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ventricular Rate Regulation feature ON
Arm Type
Experimental
Arm Title
Ventricular Rate Regulation feature OFF
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CRT devices with ventricular rate regulation [VRR] (CE labeled)
Primary Outcome Measure Information:
Title
Percentage of Biventricular Pacing
Description
Comparison of the average percentage of biventricular pacing in subjects randomised to Ventricular Rate Regulation (VRR) = ON to subjects randomized to VRR = OFF
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Correlation Between VRR and the Subjective Quality of Life
Description
Correlation between VRR mode and the subjective quality of life (QOL) measured by a QOL questionnaire in both randomized groups
Time Frame
6 Month
Title
Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
Description
Correlation between VRR mode and conducted atrial arrhythmias (if observed) in both randomized groups
Time Frame
6 months
Title
Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
Description
Correlation between VRR and physical ability in both randomized groups measured by a 6 minute walk test or an optional spiroergometry
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Lemke, MD
Organizational Affiliation
Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Lüdenscheid / Kardiologie
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
MODULA Modul 7 VRR
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