Atrial FibrillationPRESSURENCT01942408
The Effect of Early Repeat Atrial Fibrillation (AF) Ablation on AF Recurrence
A study testing Repeat PVI in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and causes an irregular and often rapid heartbeat. Developing this condition may cause significant health problems and symptoms that affect normal day-to-day activities. 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?
- Repeat PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- Current pattern of paroxysmal AF (defined as electrocardiogram (ECG)-proven episodes of AF which are self-limiting and last less than 7 days on each occasion, or which were cardioverted electrically or pharmacologically less than 48 hours from onset)
- Due to undergo pulmonary vein isolation by radiofrequency (RF) ablation
Who cannot join
- Inability or unwillingness to receive oral anticoagulation with warfarin or alternative anticoagulant drug
- Previous ablation procedure for AF
- Unwillingness or inability to complete the required follow-up arrangements
- Current pattern of persistent (episodes of AF which last longer than 7 days or which last longer than 48 hours but require electrical or pharmacological cardioversion) or permanent AF
- Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
- Reversible cause for AF
Show all 9Show fewer
- Known infiltrative cardiomyopathy
- Known severe left ventricular systolic function (ejection fraction <35%)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, L14 3PE
About this study
Official title: Pulmonary Vein Re-isolation as a Routine Strategy: a Success Rate Evaluation
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and causes an irregular and often rapid heartbeat. Developing this condition may cause significant health problems and symptoms that affect normal day-to-day activities. Patients with AF also have a shorter life expectancy on average. Tablets used to try to normalise the heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure this condition. Special wires (called catheters) are used to deliver heat energy (called ablation) on the inside surface of the heart. This technique has been used more and more in recent years for patients with troublesome symptoms due to AF.
The aim of the treatment is to draw lines of ablation in specific places in the heart. Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of these patients have a second treatment performed. It is usually found at this second treatment that gaps have developed in the lines of ablation that were drawn the first time around. The investigators think that electively doing a second treatment to close these gaps a couple of months after the first treatment may mean that fewer of these patients will get AF again in the future. The investigators also want to find out what factors make a line of ablation less likely to develop gaps.
Read more
In this study, participants will be assigned to one of two groups:
- a "standard care" group, who will have a single treatment initially.
- a "repeat study" group, who will have the initial treatment followed by a second treatment 8-10 weeks later.
For patients in the "repeat study group", investigators will see how many have developed gaps since their first treatment. The investigators will look at where these gaps are and will compare this with information collected during the first treatment to try to work out why the gap has developed. Any gaps found at the second treatment will be closed again.
All participants will then be monitored carefully over 12 months to see how many from each group get AF again. To do this, all participants will be given a handheld heart rhythm monitor to keep until the end of the study. This device is simple to use. Participants will be asked to make a 30 second recording of their heart rhythm each day and also whenever they have symptoms. These recordings will be downloaded at review appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Repeat PVI
- Keywords
- Atrial fibrillation, Pulmonary vein isolation, Pulmonary vein reconnection
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat PVIProcedure or surgery
Repeat EP study 8-10 weeks post-initial PVI with re-isolation of PV reconnection
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | No intervention | Patients will undergo an initial PVI procedure. Further management will be determined by AF recurrences at the responsible Consultant's discretion as per standard care. |
| Repeat study group | Active comparator | Following an initial PVI procedure, all patients (regardless of early AF recurrence) will undergo a repeat electrophysiology (EP) study at 8-10 weeks post-initial PVI, with repeat PVI of any PV reconnection identified Receives: Procedure: Repeat PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmia (AT) recurrence
The proportion of patients maintaining freedom from AT for 12 months post-initial PVI (after an initial 12 week blanking period)
Measured: 12 months post-initial pulmonary vein isolation (PVI)
Secondary outcomes (3)
Quality of life measures
Quality of life 12 months after initial ablation, as quantified by the validated Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.
Measured: 12 months post-initial PVI
Time to recurrence
Time to first AT recurrence after the initial blanking period
Measured: 12 months post-initial PVI
Comparison of major complication rates
Comparison of major complication rates (occurring within 30 days after a PVI procedure), to include cardiac tamponade, stroke/transient ischemic attack (TIA), myocardial infarction, pulmonary vein stenosis, phrenic nerve paralysis, oesophageal perforation/atrio-oesophageal fistula, major vascular complications and death
Measured: 4 months post-initial PVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
- Investigators
- Dhiraj Gupta, DM, MD, FRCP, Principal investigator, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942408
- Sponsor's protocol ID
- LHCH967
- Other IDs
- BWI-IIS-0239
- Acronym
- PRESSURE
- Status last verified
- Mar 2016
- First submitted
- 10 Sep 2013
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Das M, Wynn GJ, Saeed Y, Gomes S, Morgan M, Ronayne C, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Pulmonary Vein Re-Isolation as a Routine Strategy Regardless of Symptoms: The PRESSURE Randomized Controlled Trial. JACC Clin Electrophysiol. 2017 Jun;3(6):602-611. doi: 10.1016/j.jacep.2017.01.016. Epub 2017 Mar 29.
PubMed 29759434
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Re-isolation as a Routine Strategy: a Success Rate Evaluation
- ClinicalTrials.gov ID
- NCT01942408
- Acronym / sponsor ID
- PRESSURE / LHCH967
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Pulmonary vein isolation, Pulmonary vein reconnection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Sep 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.
Atrial fibrillation (AF) is the commonest condition affecting the rhythm of the heart and causes an irregular and often rapid heartbeat. Developing this condition may cause significant health problems and symptoms that affect normal day-to-day activities. Patients with AF also have a shorter life expectancy on average. Tablets used to try to normalise the heart rhythm rarely work well. As a result, doctors have devised a treatment to try to cure this condition. Special wires (called catheters) are used to deliver heat energy (called ablation) on the inside surface of the heart. This technique has been used more and more in recent years for patients with troublesome symptoms due to AF.
The aim of the treatment is to draw lines of ablation in specific places in the heart. Unfortunately, a lot of patients (almost 50%) get AF again after this treatment and most of these patients have a second treatment performed. It is usually found at this second treatment that gaps have developed in the lines of ablation that were drawn the first time around. The investigators think that electively doing a second treatment to close these gaps a couple of months after the first treatment may mean that fewer of these patients will get AF again in the future. The investigators also want to find out what factors make a line of ablation less likely to develop gaps.
In this study, participants will be assigned to one of two groups:
- a "standard care" group, who will have a single treatment initially.
- a "repeat study" group, who will have the initial treatment followed by a second treatment 8-10 weeks later.
For patients in the "repeat study group", investigators will see how many have developed gaps since their first treatment. The investigators will look at where these gaps are and will compare this with information collected during the first treatment to try to work out why the gap has developed. Any gaps found at the second treatment will be closed again.
All participants will then be monitored carefully over 12 months to see how many from each group get AF again. To do this, all participants will be given a handheld heart rhythm monitor to keep until the end of the study. This device is simple to use. Participants will be asked to make a 30 second recording of their heart rhythm each day and also whenever they have symptoms. These recordings will be downloaded at review appointments arranged 6 weeks, 3 months, 6 months and 12 months after the initial ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | No intervention | –Patients will undergo an initial PVI procedure. Further management will be determined by AF recurrences at the responsible Consultant's discretion as per standard care. |
| Repeat study group | Active comparator | Procedure: Repeat PVIFollowing an initial PVI procedure, all patients (regardless of early AF recurrence) will undergo a repeat electrophysiology (EP) study at 8-10 weeks post-initial PVI, with repeat PVI of any PV reconnection identified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- Current pattern of paroxysmal AF (defined as electrocardiogram (ECG)-proven episodes of AF which are self-limiting and last less than 7 days on each occasion, or which were cardioverted electrically or pharmacologically less than 48 hours from onset)
- Due to undergo pulmonary vein isolation by radiofrequency (RF) ablation
Key exclusion criteria (9 listed)
- Inability or unwillingness to receive oral anticoagulation with warfarin or alternative anticoagulant drug
- Previous ablation procedure for AF
- Unwillingness or inability to complete the required follow-up arrangements
- Current pattern of persistent (episodes of AF which last longer than 7 days or which last longer than 48 hours but require electrical or pharmacological cardioversion) or permanent AF
- Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
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 |
|---|---|---|
| Repeat PVIRepeat EP study 8-10 weeks post-initial PVI with re-isolation of PV reconnection | Procedure or surgery | Repeat study group |
Primary outcome
Atrial tachyarrhythmia (AT) recurrence
Time frame: 12 months post-initial pulmonary vein isolation (PVI)
The proportion of patients maintaining freedom from AT for 12 months post-initial PVI (after an initial 12 week blanking period)
3 secondary outcomes
Quality of life measures
Time frame: 12 months post-initial PVI
Time to recurrence
Time frame: 12 months post-initial PVI
Comparison of major complication rates
Time frame: 4 months post-initial PVI
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 3 Mar 2016.
- Derived from this study: PubMed 29759434Das M, Wynn GJ, Saeed Y, Gomes S, Morgan M, Ronayne C, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Pulmonary Vein Re-Isolation as a Routine Strategy Regardless of Symptoms: The PRESSURE Randomized Controlled Trial. JACC Clin Electrophysiol. 2017 Jun;3(6):602-611. doi: 10.1016/j.jacep.2017.01.016. Epub 2017 Mar 29.
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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.
Dhiraj Gupta, DM, MD, FRCP principal investigator
Liverpool Heart and Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeat PVI in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital 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 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: finished, as of the sponsor's last update on 3 Mar 2016. 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?
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?
Atrial tachyarrhythmia (AT) recurrence (time frame: 12 months post-initial pulmonary vein isolation (PVI)). 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 NCT01942408, which also lists 1 linked publication.
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 3 Mar 2016.