Study Stopped
low enrolment rate
MODULA Modul 7 VRR
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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Aug 2004
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2008
CompletedResults Posted
Study results publicly available
March 29, 2022
CompletedJune 24, 2022
June 1, 2022
3.7 years
September 12, 2005
June 22, 2021
June 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 month
Secondary Outcomes (3)
Correlation Between VRR and the Subjective Quality of Life
6 Month
Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
6 months
Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
6 months
Study Arms (2)
Ventricular Rate Regulation feature ON
EXPERIMENTALVentricular Rate Regulation feature OFF
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with third degree atrioventricular (AV) block
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- Guidant Corporationcollaborator
Study Sites (1)
Klinikum Lüdenscheid / Kardiologie
Lüdenscheid, 58515, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jens Goetzke
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Bernd Lemke, MD
Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 16, 2005
Study Start
August 28, 2004
Primary Completion
May 7, 2008
Study Completion
May 7, 2008
Last Updated
June 24, 2022
Results First Posted
March 29, 2022
Record last verified: 2022-06