Atrial FibrillationIBAD-AFIBNCT00589992
Ibutilide Administration During Pulmonary Vein Ablation
A study testing Ibutilide fumarate in people with Atrial Fibrillation and Pulmonary Vein Ablation, run by Ball Memorial Hospital at 1 site in United States.
Trial summary
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Pulmonary Vein Ablation
- What is being tested?
- Ibutilide fumarate
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients to be scheduled for atrial fibrillation radio frequency ablation
- paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment
- symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion
- patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone
Who cannot join
- patients with recent major hemorrhage (within 6 months)
- patients with a coagulopathy
- patients who are pregnant or breast feeding
- patients with acute congestive heart failure
- patients with hypokalemia or hyperkalemia
- patients with a prolonged QTc > 440mms
Show all 13Show fewer
- patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I
- patients with left ventricular dysfunction < 40%
- patients with a history of recent MI (< 1 month)
- patients with a history of an angioplasty of < 1 month
- patients with a history of coronary artery bypass grafting surgery of < 3 months.
- patients with a history of chronic renal failure or a creatinine clearance of < 30ml/m
- patients with a history of stroke of < 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Consultants, P.C.
Muncie, Indiana, 47303
Sherry Adair, RN, 765-254-4761, skadair@medicalconsultantspc.com
Antonio Navarrete, MD
About this study
Official title: Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.
- Conditions
- Atrial Fibrillation, Pulmonary Vein Ablation
- Being tested
- Ibutilide fumarate
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibutilide fumarateDrug
During scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
Measured: one year
Secondary outcomes (3)
To compare the ibutilide response in patients with paroxysmal versus permanent Afib
Measured: one year
To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide.
Measured: one year
To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Investigators
- Antonio Navarrete, MD, Principal investigator, Staff Physician, Ball Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589992
- Sponsor's protocol ID
- BMH study #762
- Acronym
- IBAD-AFIB
- Status last verified
- Jan 2012
- First submitted
- 26 Dec 2007
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.
- ClinicalTrials.gov ID
- NCT00589992
- Acronym / sponsor ID
- IBAD-AFIB / BMH study #762
- Conditions
- Atrial Fibrillation, Pulmonary Vein Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ball Memorial HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Oct 2007
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jan 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.
To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients to be scheduled for atrial fibrillation radio frequency ablation
- paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment
- symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion
- patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone
Key exclusion criteria (13 listed)
- patients with recent major hemorrhage (within 6 months)
- patients with a coagulopathy
- patients who are pregnant or breast feeding
- patients with acute congestive heart failure
- patients with hypokalemia or hyperkalemia
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 |
|---|---|---|
| Ibutilide fumarateDuring scheduled radio frequency ablation for atrial fibrillation patients will be infused with 1mg of ibutilide over 10 minutes. | Drug | – |
Primary outcome
To discern the basic mechanism of Afib by studying its response to Ibutilide administration.
Time frame: one year
3 secondary outcomes
To compare the ibutilide response in patients with paroxysmal versus permanent Afib
Time frame: one year
To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide.
Time frame: one year
To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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.
Antonio Navarrete, MD principal investigator
Staff Physician, Ball Memorial 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 Ibutilide fumarate in people with Atrial Fibrillation and Pulmonary Vein Ablation, run by Ball Memorial Hospital at 1 site 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Jan 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Navarrete, MD (765-281-2000, annavarr@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To discern the basic mechanism of Afib by studying its response to Ibutilide administration. (time frame: one year). 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 31 Jan 2012.