Atrial FlutterNCT00606463
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
A study testing Cardiac Ablation (Gen2 Cardiac Ablation System) in people with Atrial Flutter, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
Irrigated catheter for ablation of isthmus-dependent 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?
- Cardiac Ablation (Gen2 Cardiac Ablation System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Jan 2009
- 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
- Scheduled for ablation of isthmus-dependent atrial flutter
Who cannot join
- Prior ablation of isthmus-dependent atrial flutter
- Atypical or scar flutter
- Significant heart disease
- Intracardiac thrombus
- Prior cardiac surgery (within 1 month)
- Contraindication to heparin
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama Birmingham
Birmingham, Alabama
Doylestown Hospital
Doylestown, Pennsylvania
St. Barnabus Medical Center
West Orange, New Jersey
About this study
Official title: Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study
Irrigated catheter for ablation of isthmus-dependent atrial flutter
Read the detailed description
This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter
- Conditions
- Atrial Flutter
- Being tested
- Cardiac Ablation (Gen2 Cardiac Ablation System)
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Ablation (Gen2 Cardiac Ablation System)Device
Ablation of isthmus-dependent atrial flutter
| Study group | Role | What they receive |
|---|---|---|
| (Gen2 Cardiac Ablation System) | Experimental | Ablation of isthmus-dependent atrial flutter Receives: Device: Cardiac Ablation (Gen2 Cardiac Ablation System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraprocedural, serious cardiac adverse event
Defined as the Incidence of intraprocedural, serious cardiac adverse event
Measured: 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionJan 2009
Why it stopped: Abbott funding allocated to a different project.
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 Abbott Medical DevicesThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vance Plumb, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606463
- Sponsor's protocol ID
- 0611.1
- Status last verified
- Jul 2023
- First submitted
- 21 Jan 2008
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study
- ClinicalTrials.gov ID
- NCT00606463
- Acronym / sponsor ID
- 0611.1
- Conditions
- Atrial Flutter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Abbott funding allocated to a different project.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 4 Feb 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.
Irrigated catheter for ablation of isthmus-dependent atrial flutter
Detailed description
This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent 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 |
|---|---|---|
| (Gen2 Cardiac Ablation System) | Experimental | Device: Cardiac Ablation (Gen2 Cardiac Ablation System)Ablation of isthmus-dependent atrial flutter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for ablation of isthmus-dependent atrial flutter
Key exclusion criteria (6 listed)
- Prior ablation of isthmus-dependent atrial flutter
- Atypical or scar flutter
- Significant heart disease
- Intracardiac thrombus
- Prior cardiac surgery (within 1 month)
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 |
|---|---|---|
| Cardiac Ablation (Gen2 Cardiac Ablation System)Ablation of isthmus-dependent atrial flutter | Device | (Gen2 Cardiac Ablation System) |
Primary outcome
Incidence of intraprocedural, serious cardiac adverse event
Time frame: 7 days post-procedure
Defined as the Incidence of intraprocedural, serious cardiac adverse event
Results and safety
The study was stopped early (reason given: Abbott funding allocated to a different project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Vance Plumb, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Ablation (Gen2 Cardiac Ablation System) in people with Atrial Flutter, run by Abbott Medical Devices at 3 sites in United States.
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 1 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: stopped early, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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: Abbott funding allocated to a different project.). 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?
Incidence of intraprocedural, serious cardiac adverse event (time frame: 7 days post-procedure). 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 14 Jul 2023.