Atrial FibrillationNCT00180414
MODULA Modul 7 VRR
A study testing CRT devices with ventricular rate regulation [VRR] (CE labeled) in people with Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CRT devices with ventricular rate regulation [VRR] (CE labeled)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2004to 7 May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with third degree atrioventricular (AV) block
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- CRT devices with ventricular rate regulation [VRR] (CE labeled)
- Keywords
- heart failure
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT devices with ventricular rate regulation [VRR] (CE labeled)Device
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Rate Regulation feature ON | Experimental | Not described Receives: Device: CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| Ventricular Rate Regulation feature OFF | Active comparator | Not described Receives: Device: CRT devices with ventricular rate regulation [VRR] (CE labeled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Secondary outcomes (3)
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
Measured: 6 Month
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
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start28 Aug 2004
- Primary completion7 May 2008
- Study completion7 May 2008
Why it stopped: low enrolment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
- Investigators
- Bernd Lemke, MD, Principal investigator, Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180414
- Sponsor's protocol ID
- Version vom 10.07.2003 BIS
- Status last verified
- Jun 2022
- First submitted
- 12 Sep 2005
- Last updated
- 24 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00180414
- Acronym / sponsor ID
- Version vom 10.07.2003 BIS
- Conditions
- Atrial Fibrillation
- Keywords
- heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrolment rate
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- 28 Aug 2004 (actual)
- Primary completion
- 7 May 2008 (actual)
- Study completion
- 7 May 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 29 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular Rate Regulation feature ON | Experimental | Device: CRT devices with ventricular rate regulation [VRR] (CE labeled) |
| Ventricular Rate Regulation feature OFF | Active comparator | Device: CRT devices with ventricular rate regulation [VRR] (CE labeled) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with third degree atrioventricular (AV) block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT devices with ventricular rate regulation [VRR] (CE labeled) | Device | Ventricular Rate Regulation feature OFF, Ventricular Rate Regulation feature ON |
Primary outcome
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
3 secondary outcomes
Correlation Between VRR and the Subjective Quality of Life
Time frame: 6 Month
Correlation Between VRR and the Symptoms Caused by Conducted Atrial Arrhythmias
Time frame: 6 months
Correlation Between VRR and Physical Ability (6 Minute Walk Test, Optional Spiroergometry)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Lemke, MD principal investigator
Klinikum Lüdenscheid / Kardiologie / Paulmannshöher Straße 14 / 58515 Lüdenscheid / Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRT devices with ventricular rate regulation [VRR] (CE labeled) in people with Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Biventricular Pacing (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.