Atrial FibrillationFORMIDIBLENCT02666729
Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins
An observational study of Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial summary
The purpose of this study is to collect information about the success rate of atrial fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz ablation catheter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AF Ablation with contact force information and AF Ablation without contact force information
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who are undergoing an intial AF ablation procedure.
Who may be able to join
- Patients undergoing an initial AF ablation procedure
- Able to sign informed consent and complete the 3 month follow up
Who cannot join
- Severe COPD and is unable to receive adenosine therapy during the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to collect information about the success rate of atrial fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz ablation catheter.
Read the detailed description
Atrial fibrillation is a condition in which the upper chambers of the heart (the atria) begin to quiver (shake rapidly with small movements) instead of beating in a normal rhythm. This condition can cause blood to remain in the atria instead of moving to the lower heart chambers. AF can cause a number of other health problems and can decrease your quality of life.
Treatments for AF can include surgery, implantable devices, ablation and medication, to name a few. An ablation is a procedure that creates scar tissue in the heart to interrupt irregular heart rhythms and prevent them from coming back. The ablation procedure uses tools called catheters to treat the AF. Ablation catheters are thin, flexible plastic tubes that use electrical energy to create scars in the heart.
The amount of force applied to the heart tissue where the catheter touches (called the contact force) might help determine the success of the ablation procedure. This study would help to determine whether or not the contact force makes a difference in an effective ablation. You will be tested on both sides, at the end of the procedure to see if any problem persists.
Participants will be in this study for about 3 months. All visits in this study will correspond to standard of care visits.
- Conditions
- Atrial Fibrillation
- Being tested
- AF Ablation with contact force information, AF Ablation without contact force information
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF Ablation with contact force informationProcedure or surgery
Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will be made aware of contact force data when performing procedure.
AF Ablation without contact force informationProcedure or surgery
Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will not be made aware of contact force data when performing procedure.
| Study group | Role | What they receive |
|---|---|---|
| AF Ablation Procedure | Patients with AF who are schedule for a first time pulmonary vein isolation (PVI) for AF using the TactiCath catheter. Patients will have four pulmonary veins ablated during procedure. The researcher will perform AF Ablation with contact force information on two veins. The research will perform AF Ablation without contact force information on the other two veins. Receives: Procedure: AF Ablation with contact force information; Procedure: AF Ablation without contact force information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of dormant conduction
Comparison of rates between pulmonary veins where the contact force information was known to researcher during ablation procedure versus contact force information NOT known during procedure
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACC
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor-investigator, Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666729
- Sponsor's protocol ID
- STUDY00003285
- Acronym
- FORMIDIBLE
- Status last verified
- Jul 2016
- First submitted
- 25 Jan 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Contact Force Sensing Catheter for AF Ablation - Impact of TactiCath on Dormant Conduction Across the Pulmonary Veins
- ClinicalTrials.gov ID
- NCT02666729
- Acronym / sponsor ID
- FORMIDIBLE / STUDY00003285
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Jan 2016 (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.
The purpose of this study is to collect information about the success rate of atrial fibrillation (AF) ablation procedures using the contact force data from the TactiCath Quartz ablation catheter.
Detailed description
Atrial fibrillation is a condition in which the upper chambers of the heart (the atria) begin to quiver (shake rapidly with small movements) instead of beating in a normal rhythm. This condition can cause blood to remain in the atria instead of moving to the lower heart chambers. AF can cause a number of other health problems and can decrease your quality of life.
Treatments for AF can include surgery, implantable devices, ablation and medication, to name a few. An ablation is a procedure that creates scar tissue in the heart to interrupt irregular heart rhythms and prevent them from coming back. The ablation procedure uses tools called catheters to treat the AF. Ablation catheters are thin, flexible plastic tubes that use electrical energy to create scars in the heart.
The amount of force applied to the heart tissue where the catheter touches (called the contact force) might help determine the success of the ablation procedure. This study would help to determine whether or not the contact force makes a difference in an effective ablation. You will be tested on both sides, at the end of the procedure to see if any problem persists.
Participants will be in this study for about 3 months. All visits in this study will correspond to standard of care visits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AF Ablation Procedure | – | Procedure: AF Ablation with contact force information, Procedure: AF Ablation without contact force informationPatients with AF who are schedule for a first time pulmonary vein isolation (PVI) for AF using the TactiCath catheter. Patients will have four pulmonary veins ablated during procedure. The researcher will perform AF Ablation with contact force information on two veins. The research will perform AF Ablation without contact force information on the other two veins. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who are undergoing an intial AF ablation procedure.
Key inclusion criteria (2 listed)
- Patients undergoing an initial AF ablation procedure
- Able to sign informed consent and complete the 3 month follow up
Key exclusion criteria (1 listed)
- Severe COPD and is unable to receive adenosine therapy during the procedure
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 |
|---|---|---|
| AF Ablation with contact force informationAblation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will be made aware of contact force data when performing procedure. | Procedure or surgery | AF Ablation Procedure |
| AF Ablation without contact force informationAblation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will not be made aware of contact force data when performing procedure. | Procedure or surgery | AF Ablation Procedure |
Primary outcome
Rates of dormant conduction
Time frame: intraoperative
Comparison of rates between pulmonary veins where the contact force information was known to researcher during ablation procedure versus contact force information NOT known during procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
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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.
Dhanunjaya Lakkireddy, MD principal investigator
University of Kansas Medical Center
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 Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 Jul 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rates of dormant conduction (time frame: intraoperative). 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 11 Jul 2016.