Atrial FibrillationNCT04264117
Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
A study testing FlexAbility (Mesh-like irrigated tip catheter) group and TactiCath (Contract force monitoring catheter) group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- FlexAbility (Mesh-like irrigated tip catheter) group and TactiCath (Contract force monitoring catheter) group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to May 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Appropriate indiction for AF catheter ablation (20~80 years old)
- Echocardiographically measured left atrial size < 55mm
- Anticoagulation eligible patients
Who cannot join
- AF associated with significant cardiac anomaly, structural heart disease affecting hemodynamics
- Ineligible to CT imaging due to significant renal disease
- Prior history of AF catheter ablation or cardiac surgery
- Active internal bleeding
- Anticoagulation ineligible patients
- Valvular AF
Show all 9Show fewer
- Life expectancy < 1year
- Drug or alcohol addicted patients
- Other unacceptable patients for clinical trial determined by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul
About this study
Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA).
The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner.
The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.
Read the detailed description
- Study design
- Prospective randomization (FlexAbility group vs. TactiCath group )
- Target number of subjects: 360 (180 per group)
- Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 2 weeks, 2 months, and thereafter every 6-month.
- Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
- Conditions
- Atrial Fibrillation
- Being tested
- FlexAbility (Mesh-like irrigated tip catheter) group, TactiCath (Contract force monitoring catheter) group
- Keywords
- Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexAbility (Mesh-like irrigated tip catheter) groupProcedure or surgery
- AF catheter ablation (PV isolation and linear ablations)
- 30 sec ablation in each point
- 35W in anterior LA, 30 W in posterior LA
- Irrigation flow rate 13mL/min
- Measuring procedure time, Ablation time
- Rhythm follow-up based on guidelines
TactiCath (Contract force monitoring catheter) groupProcedure or surgery
- AF catheter ablation (PV isolation and linear ablations)
- contact force >10g, target force-time integral 400 in each point
- 35W in anterior LA, 30 W in posterior LA
- Irrigation flow rate 15mL/min at 30W ablation, 30mL/min at 35W ablation
- Measuring procedure time, Ablation time
- Rhythm follow-up based on guidelines
| Study group | Role | What they receive |
|---|---|---|
| FlexAbility (Mesh-like irrigated tip catheter) group | Active comparator | Not described Receives: Procedure: FlexAbility (Mesh-like irrigated tip catheter) group |
| TactiCath (Contract force monitoring catheter) group | Experimental | Not described Receives: Procedure: TactiCath (Contract force monitoring catheter) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
Measured: 1 month after the procedure
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Measured: 12 months after the procedure
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Measured: 24 months after the procedure
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Measured: 12 months after the procedure
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Measured: 24 months after the procedure
Secondary outcomes (7)
procedure time
Measured: intraoperative
RF energy delivery time
Measured: within 30 minutes after the procedure
volume of irrigated saline infusion
Measured: within 30 minutes after the procedure
post-procedural readmission rate
Measured: 12 months after the procedure
post-procedural readmission rate
Measured: 24 months after the procedure
post-procedural cardioversion rate
Measured: 12 months after the procedure
post-procedural cardioversion rate
Measured: 24 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jun 2017
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (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.
- More trials run by Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264117
- Sponsor's protocol ID
- 1-2017-0019
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
- ClinicalTrials.gov ID
- NCT04264117
- Acronym / sponsor ID
- 1-2017-0019
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 11 Feb 2020 (actual)
- 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.
Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA).
The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner.
The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.
Detailed description
- Study design
- Prospective randomization (FlexAbility group vs. TactiCath group )
- Target number of subjects: 360 (180 per group)
- Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)
- Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
- All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.
- Progress and rhythm/ECG follow-up
- To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
- Follow-up at 2 weeks, 2 months, and thereafter every 6-month.
- Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter
- If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FlexAbility (Mesh-like irrigated tip catheter) group | Active comparator | Procedure: FlexAbility (Mesh-like irrigated tip catheter) group |
| TactiCath (Contract force monitoring catheter) group | Experimental | Procedure: TactiCath (Contract force monitoring catheter) group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Appropriate indiction for AF catheter ablation (20~80 years old)
- Echocardiographically measured left atrial size < 55mm
- Anticoagulation eligible patients
Key exclusion criteria (9 listed)
- AF associated with significant cardiac anomaly, structural heart disease affecting hemodynamics
- Ineligible to CT imaging due to significant renal disease
- Prior history of AF catheter ablation or cardiac surgery
- Active internal bleeding
- Anticoagulation ineligible patients
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 |
|---|---|---|
| FlexAbility (Mesh-like irrigated tip catheter) group1. AF catheter ablation (PV isolation and linear ablations) 2. 30 sec ablation in each point 3. 35W in anterior LA, 30 W in posterior LA 4. Irrigation flow rate 13mL/min 5. Measuring procedure time, Ablation time 6. Rhythm follow-up based on guidelines | Procedure or surgery | FlexAbility (Mesh-like irrigated tip catheter) group |
| TactiCath (Contract force monitoring catheter) group1. AF catheter ablation (PV isolation and linear ablations) 2. contact force >10g, target force-time integral 400 in each point 3. 35W in anterior LA, 30 W in posterior LA 4. Irrigation flow rate 15mL/min at 30W ablation, 30mL/min at 35W ablation 5. Measuring procedure time, Ablation time 6. Rhythm follow-up based on guidelines | Procedure or surgery | TactiCath (Contract force monitoring catheter) group |
Primary outcome
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
Time frame: 1 month after the procedure
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Time frame: 12 months after the procedure
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Time frame: 24 months after the procedure
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Time frame: 12 months after the procedure
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Time frame: 24 months after the procedure
7 secondary outcomes
procedure time
Time frame: intraoperative
RF energy delivery time
Time frame: within 30 minutes after the procedure
volume of irrigated saline infusion
Time frame: within 30 minutes after the procedure
post-procedural readmission rate
Time frame: 12 months after the procedure
post-procedural readmission rate
Time frame: 24 months after the procedure
post-procedural cardioversion rate
Time frame: 12 months after the procedure
post-procedural cardioversion rate
Time frame: 24 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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CONVERGE Post-Approval Study (PAS)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlexAbility (Mesh-like irrigated tip catheter) group and TactiCath (Contract force monitoring catheter) group in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 9 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 12 Feb 2020. 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 South Korea. 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?
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?
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month (time frame: 1 month after the procedure). The study lists 5 primary outcomes in all. 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 12 Feb 2020.