Atrial FibrillationPhase 4RAPID XTNCT00789139
Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
A Phase 4 study testing ICM Implantation in people with Atrial Fibrillation, run by Dr Ange FERRACCI at 1 site in France.
Trial summary
Post Marketing study, Interventional, Prospective, non randomised Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ICM Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jul 2013
- 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
- AF thermoablation indication
- Informed Consent signed,
- Age between 18 \& 75
Who cannot join
- Participation to other clinical trial
- Non compliant patient
- Pregnant women
- Left Atrial thrombus
- Endocarditis, infection
Trial locations and contacts
1 site in 1 country.
About this study
Post Marketing study, Interventional, Prospective, non randomised
Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).
- Conditions
- Atrial Fibrillation
- Being tested
- ICM Implantation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICM ImplantationDevice
Sub cutaneous implantation of the ICM
| Study group | Role | What they receive |
|---|---|---|
| AF monitoring by ICM | Other | Only one arm Receives: Device: ICM Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical exam and ECG record
Measured: one month, 3 months, 6 months , 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Ange FERRACCI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Ange FERRACCI, Hospital St. Joseph, Marseille, France
- Investigators
- ANGE FERRACCI, md, Principal investigator, Unity Health TorontoANDRE PISAPIA, MD, Study director, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789139
- Sponsor's protocol ID
- RAPIDXT
- Acronym
- RAPID XT
- Status last verified
- Jun 2015
- First submitted
- 10 Nov 2008
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
- ClinicalTrials.gov ID
- NCT00789139
- Acronym / sponsor ID
- RAPID XT / RAPIDXT
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Dr Ange FERRACCIUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Nov 2008 (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.
Post Marketing study, Interventional, Prospective, non randomised
Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF monitoring by ICM | Other | Device: ICM ImplantationOnly one arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AF thermoablation indication
- Informed Consent signed,
- Age between 18 \& 75
Key exclusion criteria (5 listed)
- Participation to other clinical trial
- Non compliant patient
- Pregnant women
- Left Atrial thrombus
- Endocarditis, infection
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 |
|---|---|---|
| ICM ImplantationSub cutaneous implantation of the ICM | Device | AF monitoring by ICM |
Primary outcome
Clinical exam and ECG record
Time frame: one month, 3 months, 6 months , 12 months
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 19 Jun 2015.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
ANGE FERRACCI, md principal investigator
Unity Health Toronto
ANDRE PISAPIA, MD study director
Unity Health Toronto
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 ICM Implantation in people with Atrial Fibrillation, run by Dr Ange FERRACCI 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 3 inclusion and 5 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 19 Jun 2015. 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.
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 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?
Clinical exam and ECG record (time frame: one month, 3 months, 6 months , 12 months). 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 19 Jun 2015.