Persistent Atrial FibrillationABLOVO-AFNCT03811938
Ablation of Low Voltage Regions in Persistent Atrial Fibrillation
A study testing Low voltage ablation and Pulmonary Vein Isolation in people with Persistent Atrial Fibrillation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Low voltage ablation and Pulmonary Vein Isolation
- 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
- 24 Aug 2017to Jun 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable candidate for catheter mapping/ablation for arrhythmias.
- Eighteen (18) to eighty-five (85) years of age
- Body Mass Index (BMI) < 40 (Wt. in Kgs / Ht. in m2)
- Signed Informed Consent
Who cannot join
- Severe cerebrovascular disease
- Moderate to severe renal impairment (eGFR < 30)
- Active gastrointestinal bleeding
- Active infection or fever
- Short life expectancy
- Significant anemia
Show all 23Show fewer
- Severe uncontrolled systemic hypertension
- Severe electrolyte imbalance
- Ejection fraction of < 35%
- Congestive heart failure (NYHA Class IV)
- Unstable angina requiring emergent PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass graft)
- Recent myocardial infarction
- Bleeding or clotting disorders
- Uncontrolled diabetes
- Inability to receive IV or oral Anticoagulants
- Unable to give informed consent (these patients would not be recruited)
- Previous catheter or surgical ablation treatment for atrial fibrillation.
- Paroxysmal atrial fibrillation.
- Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all women of reproductive age)
- Drug and/or alcohol abuse
- Transient factors for AF
- Severe LA enlargement of >60 mm in diameter on echocardiography
- Patients who have participated in another study of an investigational medicinal product in the last 3 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital
London, W12 0HS
Szabolcs Nagy, MD, 447821694566, s.nagy@nhs.net
About this study
Official title: Catheter ABlation of Low Voltage Regions in the Treatment of Persistent Atrial Fibrillation (ABLOVO-AF Study)
Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm.
The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention.
Read more
If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods.
Goals. The study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas.
Methods. The new technology combined with the usual procedure will be compared to the usual procedure alone. All patients will receive ablation according to the new technique and results will be compared to a historical control group from the trial institution.
Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm checks.
Potential benefit. The new technique will be assessed for success at keeping patients free from persistent AF compared to the usual methods.
The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and a special research software module will be used to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Low voltage ablation, Pulmonary Vein Isolation
- Keywords
- Radiofrequency Catheter 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.
Low voltage ablationProcedure or surgery
Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.
Pulmonary Vein IsolationProcedure or surgery
Catheter ablation aiming for the electrical isolation of the pulmonary veins.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Vein Isolation | Active comparator | Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation. Receives: Procedure: Pulmonary Vein Isolation |
| Low voltage ablation | Experimental | Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation. Receives: Procedure: Low voltage ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months.
Measured: 3-12 months.
Secondary outcomes (4)
Canadian Cardiovascular Society Severity in Atrial Fibrillation Score
Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) change.
0 represents no symptoms, 4 represents symptoms that significantly interfere with quality of life and exercise capacity.
Measured: 12 months
Antiarrhythmic drugs
Change in the number of antiarrhythmic drugs per patient
Measured: 3-12 months
Number of AF ablations
Number of additional AF ablations
Measured: 3-12 months
Complication rate
Number and rate of complications in the study population.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start24 Aug 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Phang B Lim, MB BChir, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811938
- Sponsor's protocol ID
- IRAS 202816
- Acronym
- ABLOVO-AF
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter ABlation of Low Voltage Regions in the Treatment of Persistent Atrial Fibrillation (ABLOVO-AF Study)
- ClinicalTrials.gov ID
- NCT03811938
- Acronym / sponsor ID
- ABLOVO-AF / IRAS 202816
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Radiofrequency Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 22 Jan 2019 (actual)
- 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.
Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the heart. It can lead to severe complications including stroke or heart failure. It can be treated with radiofrequency ablation (RFA). This technology works by heating heart muscle inside the heart to break the electrical circuits responsible for the abnormal rhythm.
The energy is delivered into the heart with plastic tubes that have metal electrodes, inserted through the groin veins and removed after the procedure. The patient is usually put to sleep during the intervention.
If the AF has been present for more than seven days but for less than one year it is called persistent, and it can be difficult to treat successfully with the usual methods.
Goals. The study will test a new RFA technique to treat patients with persistent AF. This involves identifying areas within the left upper chamber that have a lower electrical voltage than the surrounding heart muscle and applying RFA to the border zones of these areas.
Methods. The new technology combined with the usual procedure will be compared to the usual procedure alone. All patients will receive ablation according to the new technique and results will be compared to a historical control group from the trial institution.
Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm checks.
Potential benefit. The new technique will be assessed for success at keeping patients free from persistent AF compared to the usual methods.
The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and a special research software module will be used to analyse data from the heart following ablation. The study will be sponsored by Imperial College Healthcare NHS Trust
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Vein Isolation | Active comparator | Procedure: Pulmonary Vein IsolationHistorical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation. |
| Low voltage ablation | Experimental | Procedure: Low voltage ablationActive arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suitable candidate for catheter mapping/ablation for arrhythmias.
- Eighteen (18) to eighty-five (85) years of age
- Body Mass Index (BMI) < 40 (Wt. in Kgs / Ht. in m2)
- Signed Informed Consent
Key exclusion criteria (23 listed)
- Severe cerebrovascular disease
- Moderate to severe renal impairment (eGFR < 30)
- Active gastrointestinal bleeding
- Active infection or fever
- Short life expectancy
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 |
|---|---|---|
| Low voltage ablationCatheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins. | Procedure or surgery | Low voltage ablation |
| Pulmonary Vein IsolationCatheter ablation aiming for the electrical isolation of the pulmonary veins. | Procedure or surgery | Pulmonary Vein Isolation |
Primary outcome
Atrial fibrillation recurrence
Time frame: 3-12 months.
Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months.
4 secondary outcomes
Canadian Cardiovascular Society Severity in Atrial Fibrillation Score
Time frame: 12 months
Antiarrhythmic drugs
Time frame: 3-12 months
Number of AF ablations
Time frame: 3-12 months
Complication rate
Time frame: 3-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Phang B Lim, MB BChir principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low voltage ablation and Pulmonary Vein Isolation in people with Persistent Atrial Fibrillation, run by Imperial College London 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 4 inclusion and 23 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 30 Jan 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.
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 Szabolcs Nagy, MD (447821694566, s.nagy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: 3-12 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 30 Jan 2019.