Persistent Atrial FibrillationTOUCH AFNCT01851525
Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
A study testing ThermoCoolSmartTouch ablation catheter, Biosense Webster in people with Persistent Atrial Fibrillation, run by Southlake Health at 4 sites in Canada.
Trial summary
Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- ThermoCoolSmartTouch ablation catheter, Biosense Webster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesCanada
- Study dates
- Jun 2013to 15 Feb 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Patients undergoing first-time catheter ablation for AF.
- Persistent AF defined as episodes greater than 7 days duration.
- Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
- Willing and able to provide informed consent.
Who cannot join
- Paroxysmal AF.
- AF secondary to a reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
- Patients who have previously undergone AF ablation.
- Patients with left atrial size >55 mm (echocardiography, parasternal long axis view).
- Patients who are or may potentially be pregnant.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Laval University Cardiac and Pulmonary Institute
Québec, Quebec, G1V 0A6
Vancouver Island Cardiac Arrhythmia Clinic
Victoria, British Columbia, V8R 4R2
About this study
Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:
- guided by contact force sensing (CFS) OR
- blinded to contact force sensing (CFS) - i.e. standard approach
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- ThermoCoolSmartTouch ablation catheter, Biosense Webster
- Keywords
- Atrial fibrillation, Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoCoolSmartTouch ablation catheter, Biosense WebsterDevice
| Study group | Role | What they receive |
|---|---|---|
| Contact Force Sensing (CFS) Blinded | Active comparator | Contact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) Receives: Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster |
| Contact Force Sensing (CFS) Guided | Active comparator | Contact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) Receives: Device: ThermoCoolSmartTouch ablation catheter, Biosense Webster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative radio frequency (RF) delivery time
Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)
Measured: 12 months
Secondary outcomes (15)
Freedom from AF or atrial arrhythmia >30 sec
Freedom from AF or atrial arrhythmia >30 sec at 12 months post-initial ablation
Measured: 12 months
Ability to achieve PV isolation with a single ring of lesions around each PV
Ability to achieve PV isolation with a single ring of lesions around each PV
Measured: 6 hours
Ability to achieve linear ablation with complete conduction block on the first attempt
Ability to achieve linear ablation with complete conduction block on the first attempt
Measured: 6 hours
Number & location of conduction gaps after initial circumferential ablation lines
Number \& location of conduction gaps after initial circumferential ablation lines during first ablation procedure
Measured: 6 hours
Number & location of conduction gaps after initial linear ablation
Number \& location of conduction gaps after initial linear ablation during first ablation procedure
Measured: 6 hours
Time required for successful PV isolation
Time required for successful PV isolation taking into consideration all ablation procedures
Measured: 12 months
Time required for successful linear ablation
Time required for successful linear ablation taking into consideration all ablation procedures
Measured: 12 months
Total fast anatomical mapping (FAM) time
Total FAM time taking into consideration all ablation procedures
Measured: 12 months
FAM volume
FAM volume of CFS vs non-CFS guided maps
Measured: 12 months
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
Measured: 90 days
Incidence of repeat ablation procedures
Measured: 12 months
Incidence of conduction gaps around pulmonary veins
Incidence of conduction gaps around pulmonary veins and correlation to force measures in those gaps
Measured: 12 months
Freedom from atrial arrhythmia > 30 sec
Freedom from atrial arrhythmia > 30 sec at 12 months after one procedure
Measured: 12 months
Freedom from atrial arrhythmia > 30 sec after one or two procedures
Freedom from atrial arrhythmia > 30 sec at 12 months after one or two procedures
Measured: 12 months
Reduction in atrial arrhythmia burden by >90%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJun 2013
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southlake Health
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Health Research Centre
- Responsible party
- Principal investigator, Atul Verma, Southlake Health
- Investigators
- Atul Verma, MD, Principal investigator, Southlake Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851525
- Sponsor's protocol ID
- 01
- Acronym
- TOUCH AF
- Status last verified
- Apr 2017
- First submitted
- 5 May 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Outcomes Using Contact Force Handling During Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT01851525
- Acronym / sponsor ID
- TOUCH AF / 01
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southlake HealthUniversity, hospital or other
- Collaborators
- Applied Health Research Centre
- Study start
- Jun 2013
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 10 May 2013 (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.
Catheter ablation has emerged as an effective therapy for atrial fibrillation (AF). However, achievement of complete\& durable isolation of the pulmonary veins (PVs) is challenging, primary limited both by operator experience and also the limits of currently available ablation technology. Direct contact force sensing (CFS) is a novel technology that may help to ensure adequate lesion delivery. CFS may also help to improve the safety profile of catheter ablation. The purpose of this study is to compare two strategies of wide antral PV isolation plus linear ablation for persistent AF:
- guided by contact force sensing (CFS) OR
- blinded to contact force sensing (CFS) - i.e. standard approach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Force Sensing (CFS) Blinded | Active comparator | Device: ThermoCoolSmartTouch ablation catheter, Biosense WebsterContact Force Sensing (CFS) Blinded: Operator will be blinded to data provided by the integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) |
| Contact Force Sensing (CFS) Guided | Active comparator | Device: ThermoCoolSmartTouch ablation catheter, Biosense WebsterContact Force Sensing (CFS) Guided: Operator will be guided by integrated force sensor in the ablation catheter (ThermoCoolSmartTouch ablation catheter) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years.
- Patients undergoing first-time catheter ablation for AF.
- Persistent AF defined as episodes greater than 7 days duration.
- Symptomatic AF defined as patients who have been aware of their AF anytime within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 24 months of enrolment.
Key exclusion criteria (6 listed)
- Paroxysmal AF.
- AF secondary to a reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin, coumadin, or a direct thrombin inhibitor.
- Patients who have previously undergone AF ablation.
- Patients with left atrial size >55 mm (echocardiography, parasternal long axis view).
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 |
|---|---|---|
| ThermoCoolSmartTouch ablation catheter, Biosense Webster | Device | Contact Force Sensing (CFS) Blinded, Contact Force Sensing (CFS) Guided |
Primary outcome
Total cumulative radio frequency (RF) delivery time
Time frame: 12 months
Total cumulative RF delivery time for all ablation procedures performed during the study period (12 mo)
15 secondary outcomes
Freedom from AF or atrial arrhythmia >30 sec
Time frame: 12 months
Ability to achieve PV isolation with a single ring of lesions around each PV
Time frame: 6 hours
Ability to achieve linear ablation with complete conduction block on the first attempt
Time frame: 6 hours
Number & location of conduction gaps after initial circumferential ablation lines
Time frame: 6 hours
Number & location of conduction gaps after initial linear ablation
Time frame: 6 hours
Time required for successful PV isolation
Time frame: 12 months
Time required for successful linear ablation
Time frame: 12 months
Total fast anatomical mapping (FAM) time
Time frame: 12 months
FAM volume
Time frame: 12 months
Freedom from ablation-related major adverse events at 90 days post-ablation - specifically perforation, stroke/thromboembolism, esophageal injury, and symptomatic PV stenosis
Time frame: 90 days
Incidence of repeat ablation procedures
Time frame: 12 months
Incidence of conduction gaps around pulmonary veins
Time frame: 12 months
Freedom from atrial arrhythmia > 30 sec
Time frame: 12 months
Freedom from atrial arrhythmia > 30 sec after one or two procedures
Time frame: 12 months
Reduction in atrial arrhythmia burden by >90%
Time frame: 12 months
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 25 Apr 2017.
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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.
Atul Verma, MD principal investigator
Southlake Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThermoCoolSmartTouch ablation catheter, Biosense Webster in people with Persistent Atrial Fibrillation, run by Southlake Health at 4 sites in Canada.
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 6 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: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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 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?
Total cumulative radio frequency (RF) delivery time (time frame: 12 months). 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 25 Apr 2017.