Atrioventricular BlockPhase 4BETTERNCT00559143
Biventricular Alternative Pacing
A Phase 4 study testing Biventricular Pacing (DDD(R)- BiV) in people with Atrioventricular Block, run by Medtronic Hellas Medical Devices ΑEE at 1 site in Greece.
Trial summary
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrioventricular Block
- What is being tested?
- Biventricular Pacing (DDD(R)- BiV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2007to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
- Physiologic or mildly affected systolic function of left ventricle, LVEF> 40%.
- Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
- Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.
Who cannot join
- Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
- Permanent atrial fibrillation.
- Cardiovascular surgery within the last three months prior to enrollment.
- Myocardial infarction within the last three months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
Read the detailed description
In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.
- Conditions
- Atrioventricular Block
- Being tested
- Biventricular Pacing (DDD(R)- BiV)
- Keywords
- AV conduction disturbances, LV function, Biventricular Pacing, Conductance Catheters
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular Pacing (DDD(R)- BiV)Other
Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | DDD(R)-RV pacing Receives: Other: Biventricular Pacing (DDD(R)- BiV) |
| 2 | Experimental | DDD(R)- BIV pacing Receives: Other: Biventricular Pacing (DDD(R)- BiV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
Measured: two years
Secondary outcomes (2)
Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.
Measured: two years
Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: No patients enrolled for long period of time. No scientific interest any more
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Hellas Medical Devices ΑEE
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emmanuel Simantirakis, MD, Principal investigator, University Hospital of CretePanagiotis Vardas, MD, Cardiology Professor, Study chair, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559143
- Sponsor's protocol ID
- 1111 Version 1.0- 01/May/2007
- Acronym
- BETTER
- Status last verified
- Jun 2011
- First submitted
- 15 Nov 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
- ClinicalTrials.gov ID
- NCT00559143
- Acronym / sponsor ID
- BETTER / 1111 Version 1.0- 01/May/2007
- Conditions
- Atrioventricular Block
- Keywords
- AV conduction disturbances, LV function, Biventricular Pacing, Conductance Catheters
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled for long period of time. No scientific interest any more
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Medtronic Hellas Medical Devices ΑEEIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
Detailed description
In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Biventricular Pacing (DDD(R)- BiV)DDD(R)-RV pacing |
| 2 | Experimental | Other: Biventricular Pacing (DDD(R)- BiV)DDD(R)- BIV pacing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
- Physiologic or mildly affected systolic function of left ventricle, LVEF> 40%.
- Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
- Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.
Key exclusion criteria (4 listed)
- Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
- Permanent atrial fibrillation.
- Cardiovascular surgery within the last three months prior to enrollment.
- Myocardial infarction within the last three months prior to enrollment.
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 |
|---|---|---|
| Biventricular Pacing (DDD(R)- BiV)Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV | Other | 1, 2 |
Primary outcome
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
Time frame: two years
2 secondary outcomes
Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.
Time frame: two years
Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease.
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
Related trials for Atrioventricular Block
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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.
Emmanuel Simantirakis, MD principal investigator
University Hospital of Crete
Panagiotis Vardas, MD, Cardiology Professor study chair
University Hospital of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biventricular Pacing (DDD(R)- BiV) in people with Atrioventricular Block, run by Medtronic Hellas Medical Devices ΑEE at 1 site in Greece.
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 4 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: withdrawn, as of the sponsor's last update on 8 Jun 2011. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV) (time frame: two years). 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 8 Jun 2011.