Atrial FibrillationPhase 4NCT01587404
Catheter Contact Force and Electrograms
A Phase 4 study testing THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. The electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to 21 Aug 2018
- Phase
- Phase 4
- 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
- Persistent or paroxysmal atrial fibrillation
- Listed for ablation of atrial fibrillation on clinical grounds
Who cannot join
- Contraindication to catheter ablation
- Contraindication to anticoagulation
- Contraindication to TOE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium
Until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. The electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and orientation on these signals in human heart muscle that is fibrillating is not known. New catheters have now been developed which can measure the force of contact at their tip: using these, the investigators will examine how contact force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The effect the force of contact has on the electrogram recorded will also be investigated. In so doing we hope to gain a better understanding of the relationship between tissue contact and the electrograms we measure and in so doing improve the safety and effectiveness of ablation procedures.
Hypothesis: Catheter contact force and orientation have a significant impact on the characteristics of bipolar electrograms in the fibrillating human atrium.
- Conditions
- Atrial Fibrillation
- Being tested
- THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)
- Keywords
- Atrial Fibrillation, Electrogram, Ablation, Contact Force
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)Device
Variable contact force as measured at the catheter tip within the left atrium
| Study group | Role | What they receive |
|---|---|---|
| Constant Catheter Contact Force | Experimental | No alteration of catheter contact force during recording period Receives: Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) |
| Variable catheter contact force | Experimental | change in contact force from low to high after 30seconds of recording. Receives: Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrogram characteristics
Effect of changes in contact force and orientation on: slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval
Measured: Baseline and 30 seconds
Secondary outcomes (4)
Electrogram amplitude
Measured: Baseline and 30 seconds
Electrogram responses to ablation
Slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval, amplitude change, AF cycle length, catheter impedance.
Measured: Baseline and 30 seconds
Ablation Power (Watts)
The interaction between catheter contact force and orientation and the power attained during power limited ablation
Measured: Baseline and 30 seconds
Electrogram Contact Mapping
Use of contact catheters - Constellation and/or PentaRay Catheter to record fibrillatory electrograms and identify areas of interest
Measured: During Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2012
- Primary completion31 May 2017
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J Schilling, MD, Principal investigator, Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587404
- Sponsor's protocol ID
- 007856 BLT
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2012
- Last updated
- 30 Sep 2019
- Results posted
- No
Publications
Ullah W, Hunter RJ, Baker V, Ling LH, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Impact of Catheter Contact Force on Human Left Atrial Electrogram Characteristics in Sinus Rhythm and Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1030-9. doi: 10.1161/CIRCEP.114.002483. Epub 2015 Jul 7.
PubMed 26152560Ullah W, Hunter RJ, Baker V, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Target indices for clinical ablation in atrial fibrillation: insights from contact force, electrogram, and biophysical parameter analysis. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):63-8. doi: 10.1161/CIRCEP.113.001137. Epub 2014 Jan 18.
PubMed 24443504
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Catheter Contact Force and Electrogram Characteristics in Fibrillating Human Atrial Myocardium
- ClinicalTrials.gov ID
- NCT01587404
- Acronym / sponsor ID
- 007856 BLT
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Electrogram, Ablation, Contact Force
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 30 Apr 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.
Until recently, there was no way of telling how firmly the tip of the catheter was in contact with the heart and how this contact was orientated. The electrical signals measured through the catheters, known as electrograms, are used to guide the sites and duration of ablation, but the effect of catheter contact and orientation on these signals in human heart muscle that is fibrillating is not known. New catheters have now been developed which can measure the force of contact at their tip: using these, the investigators will examine how contact force affects the electrical behaviour of heart muscle tissue in atrial fibrillation. The effect the force of contact has on the electrogram recorded will also be investigated. In so doing we hope to gain a better understanding of the relationship between tissue contact and the electrograms we measure and in so doing improve the safety and effectiveness of ablation procedures.
Hypothesis: Catheter contact force and orientation have a significant impact on the characteristics of bipolar electrograms in the fibrillating human atrium.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant Catheter Contact Force | Experimental | Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)No alteration of catheter contact force during recording period |
| Variable catheter contact force | Experimental | Device: THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)change in contact force from low to high after 30seconds of recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent or paroxysmal atrial fibrillation
- Listed for ablation of atrial fibrillation on clinical grounds
Key exclusion criteria (3 listed)
- Contraindication to catheter ablation
- Contraindication to anticoagulation
- Contraindication to TOE
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 |
|---|---|---|
| THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)Variable contact force as measured at the catheter tip within the left atrium | Device | Constant Catheter Contact Force, Variable catheter contact force |
Primary outcome
Electrogram characteristics
Time frame: Baseline and 30 seconds
Effect of changes in contact force and orientation on: slew rate, local mean cycle length, electrogram complexity and fractionation index, dominant frequency, organisation index, CFAE grade, interval confidence level, shortest complex interval and average complex interval
4 secondary outcomes
Electrogram amplitude
Time frame: Baseline and 30 seconds
Electrogram responses to ablation
Time frame: Baseline and 30 seconds
Ablation Power (Watts)
Time frame: Baseline and 30 seconds
Electrogram Contact Mapping
Time frame: During Study
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 30 Sep 2019.
- Derived from this study: PubMed 26152560Ullah W, Hunter RJ, Baker V, Ling LH, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Impact of Catheter Contact Force on Human Left Atrial Electrogram Characteristics in Sinus Rhythm and Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1030-9. doi: 10.1161/CIRCEP.114.002483. Epub 2015 Jul 7.
- Derived from this study: PubMed 24443504Ullah W, Hunter RJ, Baker V, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Target indices for clinical ablation in atrial fibrillation: insights from contact force, electrogram, and biophysical parameter analysis. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):63-8. doi: 10.1161/CIRCEP.113.001137. Epub 2014 Jan 18.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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.
Richard J Schilling, MD principal investigator
Professor of Cardiology and Electrophysiology St Barts Hospital and Queen Mary University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow) in people with Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 3 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 30 Sep 2019. 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 Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Electrogram characteristics (time frame: Baseline and 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587404, which also lists 2 linked publications.
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 30 Sep 2019.