Atrial FibrillationPhase 4NCT01629056
The Contact PVI Study: Use of Tissue Contact Data to Guide Atrial Fibrillation Ablation
A Phase 4 study testing ablation and RF ablation in people with Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. 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?
- ablation and RF ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to 3 Feb 2014
- 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
- Participant is undergoing de novo pulmonary vein isolation procedure.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, ≥18 years of age.
Who cannot join
- Previous percutaneous or open surgical procedure involving the left atrium
- Pregnancy (current or currently planning)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
John Radcliffe Hospital
Headington, Oxfordshire, Ox39DU
About this study
Official title: The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study
This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients.
The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- ablation, RF ablation
- Keywords
- atrial fibrillation, ablation, contact
- 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
Also called Irrigated RF ablation, RF ablation, Percutaneous transvenous catheter ablation
RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)
RF ablationProcedure or surgery
Also called Irrigated RF ablation, Percutaneous transvenous catheter ablation
RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)
| Study group | Role | What they receive |
|---|---|---|
| Contact ECI active | Active comparator | Contact ECI active Receives: Procedure: ablation |
| Contact information deactivated | Placebo comparator | RF ablation without contact data Receives: Procedure: RF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure
Measured: 6 months
Secondary outcomes (7)
Proportion of acute venous electrical reconnections
proportion of pulmonary veins found to be electrically reconnected to the left atrium at the end of the index procedure
Measured: acute (intra-procedure)
touch-up ablation requirements
proportion of veins requiring additional ablation after initial successful isolation, at the end of the index procedure
Measured: acute (intra-procedure)
procedure time
duration of procedure
Measured: acute
RF time
total amount of radiofrequency ablation required
Measured: acute (intra-procedure)
anatomical location of reconnections at repeat procedure
anatomical location of electrical reconnections in pulmonary vein antra, as measured at a repeat ablation procedure
Measured: at repeat ablation procerdure (6-12 months post index ablation procedure)
amount of RF required to achieve re-isolation at repeat ablation procedure
total time of RF delivery required to re-isolate the reconnected pulmonary veins at a repeat ablation procedure
Measured: at repeat ablation procedure (6-12 months post-index ablation procedure)
complications
procedure-related complications
Measured: acute and subacute (intra-procedure, and during entire follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completion3 Feb 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Jones, MBBS, Principal investigator, Oxford University Hospitals NHS TrustTim R Betts, MbCHb PhD, Study director, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629056
- Sponsor's protocol ID
- 77431/244334/1/228
- Other IDs
- 11/SC/0398
- Status last verified
- Oct 2017
- First submitted
- 25 Jun 2012
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contact-PVI Study - Does Assessment of Tissue Contact During RF Ablation Using the St. Jude Medical™ Ensite™ Contact™ System Increase Rates of Long-term Pulmonary Vein Isolation? A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT01629056
- Acronym / sponsor ID
- 77431/244334/1/228
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, contact
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- 3 Feb 2014 (actual)
- First posted
- 27 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.
This study aims to investigate the benefit of a new impedance-based computer software application during routine catheter ablation for atrial fibrillation, to see if this information improves short and long term electrical disconnection of the pulmonary veins. This study will be a single blind prospective randomised control trial in patients undergoing AF ablation. Study participants will be randomly assigned to undergo parts of their pulmonary vein ablation with, and parts of their ablation without tissue contact data displayed for the doctor performing the ablation to see. The pulmonary veins will then be studied at the end of the procedure, and at any repeat procedure in the future, to look for a difference in the recovery rate of the ablations performed using contact data, compared to those ablations performed without the use of this contact data. If a reduction in tissue recovery is achieved through the use of this tissue contact data, it may lead in the future to a reduced need for repeat ablation procedures, and better outcomes for patients.
The investigators hypothesise that the use of the Ensite™ Contact™ ECI data will reduce the recovery of conduction, and promote long-term pulmonary vein isolation in patients undergoing left atrial ablation for atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contact ECI active | Active comparator | Procedure: ablationContact ECI active |
| Contact information deactivated | Placebo comparator | Procedure: RF ablationRF ablation without contact data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is undergoing de novo pulmonary vein isolation procedure.
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, ≥18 years of age.
Key exclusion criteria (2 listed)
- Previous percutaneous or open surgical procedure involving the left atrium
- Pregnancy (current or currently planning)
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 |
|---|---|---|
| ablationAlso: Irrigated RF ablation, RF ablation, Percutaneous transvenous catheter ablationRF ablation to the left atrium of the heart, guided by ECI-contact information (active arm) | Procedure or surgery | Contact ECI active |
| RF ablationAlso: Irrigated RF ablation, Percutaneous transvenous catheter ablationRF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm) | Procedure or surgery | Contact information deactivated |
Primary outcome
The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure
Time frame: 6 months
7 secondary outcomes
Proportion of acute venous electrical reconnections
Time frame: acute (intra-procedure)
touch-up ablation requirements
Time frame: acute (intra-procedure)
procedure time
Time frame: acute
RF time
Time frame: acute (intra-procedure)
anatomical location of reconnections at repeat procedure
Time frame: at repeat ablation procerdure (6-12 months post index ablation procedure)
amount of RF required to achieve re-isolation at repeat ablation procedure
Time frame: at repeat ablation procedure (6-12 months post-index ablation procedure)
complications
Time frame: acute and subacute (intra-procedure, and during entire follow-up period)
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 13 Oct 2017.
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Paroxysmal AF
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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.
Michael A Jones, MBBS principal investigator
Oxford University Hospitals NHS Trust
Tim R Betts, MbCHb PhD study director
Oxford University Hospitals NHS Trust
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 ablation and RF ablation in people with Atrial Fibrillation, run by Oxford University Hospitals 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 3 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: finished, as of the sponsor's last update on 13 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure will be the proportion (%) of pulmonary vein pairs found to be reconnected electrically to the left atrium at a subsequent redo ablation procedure (time frame: 6 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 13 Oct 2017.