Ventricular ArrythmiasASAPNCT01169246
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
An observational study of Ventricular Arrythmias, run by MicroPort CRM at 1 site in France.
Trial summary
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmias
- How many people
- 1,254 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Feb 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD/CRT-D implanted patients population
Who may be able to join
- The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
- ATP Auto-switch function is programmed ON
Who cannot join
- Presence of a contra-indication to the ICD therapy
- Life expectancy less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.
Read the detailed description
The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.
- Conditions
- Ventricular Arrythmias
- Keywords
- ATP,CRT, ICD PARADYM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paradym VR, DR and CRT models | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Tachyarrhythmia episode
% of VT episode successfully reduced by the ATP Auto-switch
Measured: 2 years
Secondary outcomes (1)
Arrhythmia incidence
DEvice based data
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Low recruitement rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sorin Group France SAS
- Responsible party
- Sponsor
- Investigators
- SAVOURE Arnaud, MD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169246
- Sponsor's protocol ID
- RTGX02-ASAP
- Other IDs
- RTGX02
- Acronym
- ASAP
- Status last verified
- Feb 2015
- First submitted
- 22 Jul 2010
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients
- ClinicalTrials.gov ID
- NCT01169246
- Acronym / sponsor ID
- ASAP / RTGX02-ASAP
- Conditions
- Ventricular Arrythmias
- Keywords
- ATP,CRT, ICD PARADYM
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitement rate
- Enrolment
- 1,254 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Collaborators
- Sorin Group France SAS
- Study start
- Nov 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jul 2010 (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.
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.
Detailed description
The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paradym VR, DR and CRT models | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD/CRT-D implanted patients population
Key inclusion criteria (2 listed)
- The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
- ATP Auto-switch function is programmed ON
Key exclusion criteria (2 listed)
- Presence of a contra-indication to the ICD therapy
- Life expectancy less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventricular Tachyarrhythmia episode
Time frame: 2 years
% of VT episode successfully reduced by the ATP Auto-switch
1 secondary outcome
Arrhythmia incidence
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low recruitement rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
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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.
SAVOURE Arnaud, MD principal investigator
CHU Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmias, run by MicroPort CRM at 1 site in France.
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 2 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 25 Mar 2019. 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 France. 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 was stopped early (reason given: Low recruitement rate). Results are not available in the source record.
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?
Ventricular Tachyarrhythmia episode (time frame: 2 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 25 Mar 2019.