Atrial FibrillationPhase 2CFC-PVAINCT01538277
A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation
A Phase 2 study testing Contact Force during ablation and Standard ablation procedure in people with Atrial Fibrillation and Burden of Atrial Fibrillation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Burden of Atrial Fibrillation
- What is being tested?
- Contact Force during ablation and Standard ablation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Oct 2016
- Phase
- Phase 2
- 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
- Patients <75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included.
- Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included
Who cannot join
- Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction < 35% Left atrial diameter > 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)
The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.
Read the detailed description
A randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. In both groups, a catheter, which is able to measure contact force (SmartTouch, ThermoCool catheter, Biosense Webster) will be used. In the control group, the operator will be blinded to the measured contact-force. In all patients, the ablation will be guided by a circumferential mapping catheter (Lasso, Biosense Webster), CARTO 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. Follow-up will be performed by continuous monitoring using an implantable loop recorder (Reveal XT, Medtronic Inc, Minneapolis, Minn)
- Conditions
- Atrial Fibrillation, Burden of Atrial Fibrillation
- Being tested
- Contact Force during ablation, Standard ablation procedure
- Keywords
- contact force catheter, loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact Force during ablationProcedure or surgery
Radio Frequency Ablation procedure with real-time contact force information known to the operator
Standard ablation procedureOther
Standard ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| Contact Force arm | Experimental | the real-time contact force will be known to the operator Receives: Procedure: Contact Force during ablation |
| Standard | Active comparator | Standard ablation arm Receives: Other: Standard ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs
The atrial fibrillation burden defined as the percentage of time spent i atrial fibrillation monitored by an implantable cardiac loop recorder.
Measured: 12 month follow after the RFA treatment
Secondary outcomes (1)
Contact Force distribution during procedure (g/cm2) Post ablation A-fib burden(% of time in atrial fibrillation) Complications (number) Time spent on RFA of each pulmonary vein (min.) Reconnected pulmonary veins during adenosine/isoprenaline
Measured: 12 month follow up after the RFA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionOct 2016
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.
- More trials run by University of AarhusThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik k Jensen, phD, Dr Med, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538277
- Sponsor's protocol ID
- CFC-PVAI
- Acronym
- CFC-PVAI
- Status last verified
- Mar 2012
- First submitted
- 20 Feb 2012
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)
- ClinicalTrials.gov ID
- NCT01538277
- Acronym / sponsor ID
- CFC-PVAI / CFC-PVAI
- Conditions
- Atrial Fibrillation, Burden of Atrial Fibrillation
- Keywords
- contact force catheter, loop recorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Feb 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.
The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.
Detailed description
A randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. In both groups, a catheter, which is able to measure contact force (SmartTouch, ThermoCool catheter, Biosense Webster) will be used. In the control group, the operator will be blinded to the measured contact-force. In all patients, the ablation will be guided by a circumferential mapping catheter (Lasso, Biosense Webster), CARTO 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. Follow-up will be performed by continuous monitoring using an implantable loop recorder (Reveal XT, Medtronic Inc, Minneapolis, Minn)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Force arm | Experimental | Procedure: Contact Force during ablationthe real-time contact force will be known to the operator |
| Standard | Active comparator | Other: Standard ablation procedureStandard ablation arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients <75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included.
- Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included
Key exclusion criteria (1 listed)
- Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction < 35% Left atrial diameter > 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age < 18 years
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 |
|---|---|---|
| Contact Force during ablationRadio Frequency Ablation procedure with real-time contact force information known to the operator | Procedure or surgery | Contact Force arm |
| Standard ablation procedureStandard ablation procedure | Other | Standard |
Primary outcome
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs
Time frame: 12 month follow after the RFA treatment
The atrial fibrillation burden defined as the percentage of time spent i atrial fibrillation monitored by an implantable cardiac loop recorder.
1 secondary outcome
Contact Force distribution during procedure (g/cm2) Post ablation A-fib burden(% of time in atrial fibrillation) Complications (number) Time spent on RFA of each pulmonary vein (min.) Reconnected pulmonary veins during adenosine/isoprenaline
Time frame: 12 month follow up after the RFA treatment
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 28 Oct 2016.
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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.
Henrik k Jensen, phD, Dr Med study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contact Force during ablation and Standard ablation procedure in people with Atrial Fibrillation and Burden of Atrial Fibrillation, run by University of Aarhus at 1 site in Denmark.
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: finished, as of the sponsor's last update on 28 Oct 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs (time frame: 12 month follow after the RFA treatment). 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 28 Oct 2016.