Atrial FibrillationNCT01630330
Contact Force Sensing Use in Atrial Fibrillation Ablation
A study testing Ablation in people with Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients. 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?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Dec 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic AF
Who cannot join
- Recent CVA
- Contraindication to warfarin therapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton & Harefield Hospital NHS Foundation Trust
London, SW3 6NP
Tom Wong, MD, FRCP
About this study
Official title: The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.
Read the detailed description
This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.
- Conditions
- Atrial Fibrillation
- Being tested
- 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.
AblationProcedure or surgery
Atrial Fibrillation Ablation with SmartTouch catheter
AblationProcedure or surgery
Atrial Fibrillation Ablation with SmartTouch catheter
| Study group | Role | What they receive |
|---|---|---|
| Contact Force Known | Active comparator | Ablation with contact force data known Receives: Procedure: Ablation |
| Contact Force Not Known | Experimental | Contact Force data unavailable during ablation Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Pulmonary Vein Reconnection
Measured: 1 hour post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630330
- Sponsor's protocol ID
- 2012CI002B
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT01630330
- Acronym / sponsor ID
- 2012CI002B
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Jun 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.
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.
Detailed description
This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact Force Known | Active comparator | Procedure: AblationAblation with contact force data known |
| Contact Force Not Known | Experimental | Procedure: AblationContact Force data unavailable during ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic AF
Key exclusion criteria (2 listed)
- Recent CVA
- Contraindication to warfarin therapy
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 |
|---|---|---|
| AblationAtrial Fibrillation Ablation with SmartTouch catheter | Procedure or surgery | Contact Force Known |
| AblationAtrial Fibrillation Ablation with SmartTouch catheter | Procedure or surgery | Contact Force Not Known |
Primary outcome
Rate of Acute Pulmonary Vein Reconnection
Time frame: 1 hour post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation, run by Royal Brompton & Harefield NHS Foundation 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 1 inclusion and 2 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 28 Jun 2012. 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.
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?
Contact Shouvik Haldar, MRCP (0207 351 8121 ext. 8742, s.haldar@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Acute Pulmonary Vein Reconnection (time frame: 1 hour post procedure). 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 Jun 2012.