PacemakerNCT00307073
Adapta Pacing System Clinical Study
A study testing Implantable Pulse Generator in people with Pacemaker and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
Trial summary
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pacemaker, Bradycardia
- What is being tested?
- Implantable Pulse Generator
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 7 sitesin 6 countries
- Study dates
- May 2005to Nov 2005
- Phase
- Interventional
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
- Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form
Who cannot join
- Subjects with a mechanical tricuspid valve
- Subjects with a life expectancy less than two years
- Subjects with a Class III indication for permanent pacing
- Subjects with lead integrity problems, unless leads are being replaced
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
Official title: Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.
- Conditions
- Pacemaker, Bradycardia
- Being tested
- Implantable Pulse Generator
- Keywords
- Pacemaker, Managed Ventricular Pacing, Ventricular Pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Pulse GeneratorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from adverse device effects
Secondary outcomes (4)
To assess right ventricular (lower right chamber of the heart) pacing
To summarize all adverse events reported in the study
To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
To evaluate the user acceptance of TherapyGuide via questionnaire data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startMay 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Adapta Study Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307073
- Sponsor's protocol ID
- 201
- Status last verified
- Oct 2006
- First submitted
- 17 Mar 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
- ClinicalTrials.gov ID
- NCT00307073
- Acronym / sponsor ID
- 201
- Conditions
- Pacemaker, Bradycardia
- Keywords
- Pacemaker, Managed Ventricular Pacing, Ventricular Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Nov 2005
- First posted
- 27 Mar 2006 (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.
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
- Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form
Key exclusion criteria (4 listed)
- Subjects with a mechanical tricuspid valve
- Subjects with a life expectancy less than two years
- Subjects with a Class III indication for permanent pacing
- Subjects with lead integrity problems, unless leads are being replaced
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 |
|---|---|---|
| Implantable Pulse Generator | Device | – |
Primary outcome
Freedom from adverse device effects
4 secondary outcomes
To assess right ventricular (lower right chamber of the heart) pacing
To summarize all adverse events reported in the study
To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
To evaluate the user acceptance of TherapyGuide via questionnaire data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
Related trials for Pacemaker
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Not yet recruitingObservational study
AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
RecruitingPhase 4
Impact of Beta Blockers on TAVI (BETA-TAVI)
Aortic Valve Stenosis
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.
Adapta Study Team study chair
Medtronic
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Pulse Generator in people with Pacemaker and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 6 countries.
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 2 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: finished, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Czechia, Netherlands, Serbia and Montenegro and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from adverse device effects. 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 12 Oct 2006.