Atrial FlutterMiFi-CTINCT01730807
IntellaTip MiFi XP Ablation Catheter Trial
A study testing IntellaTip MiFi XP Catheter in people with Atrial Flutter, run by Boston Scientific Corporation at 1 site in Australia.
Trial summary
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- IntellaTip MiFi XP Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2013to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- indicated for ablation for Atrial Flutter
Who cannot join
- Thrombus
- Recent MI/cardiac revascularization
- Prosthetic Valves
- recent ablation for atrial flutter
- atrial flutter with reversible cause
- Class IV HF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
Read the detailed description
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.
- Conditions
- Atrial Flutter
- Being tested
- IntellaTip MiFi XP Catheter
- Keywords
- Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntellaTip MiFi XP CatheterDevice
Temperature controlled ablation catheter
| Study group | Role | What they receive |
|---|---|---|
| IntellaTip XP MiFi | Experimental | Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter Receives: Device: IntellaTip MiFi XP Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
Measured: one day
Secondary outcomes (1)
Complication Rate at procedure
Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prashanthan Sanders, MD, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730807
- Sponsor's protocol ID
- MiFi-CTI
- Acronym
- MiFi-CTI
- Status last verified
- May 2017
- First submitted
- 16 Nov 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
- ClinicalTrials.gov ID
- NCT01730807
- Acronym / sponsor ID
- MiFi-CTI / MiFi-CTI
- Conditions
- Atrial Flutter
- Keywords
- Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Nov 2012 (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.
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
Detailed description
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntellaTip XP MiFi | Experimental | Device: IntellaTip MiFi XP CatheterPatients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- indicated for ablation for Atrial Flutter
Key exclusion criteria (6 listed)
- Thrombus
- Recent MI/cardiac revascularization
- Prosthetic Valves
- recent ablation for atrial flutter
- atrial flutter with reversible cause
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 |
|---|---|---|
| IntellaTip MiFi XP CatheterTemperature controlled ablation catheter | Device | IntellaTip XP MiFi |
Primary outcome
Acute Procedural Success
Time frame: one day
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
1 secondary outcome
Complication Rate at procedure
Time frame: 7 days
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 4 May 2017.
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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.
Prashanthan Sanders, MD principal investigator
Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntellaTip MiFi XP Catheter in people with Atrial Flutter, run by Boston Scientific Corporation at 1 site in Australia.
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 6 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 4 May 2017. 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 Australia. 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?
Acute Procedural Success (time frame: one day). 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 4 May 2017.