Persistent Atrial FibrillationNCT02571218
AF Substrate Mapping and Guided Ablation
A study testing Substrate+mCPVA and mCPVA in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Italy.
Trial summary
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and… 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?
- Substrate+mCPVA and mCPVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 - 85 years of age
- Persistent AF scheduled to undergo catheter ablation with approved standard indication by ESC/EHRA guidelines
- First or second time ablation for persistent AF
- Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
Who cannot join
- Had two or more previous AF ablation procedures
- Secondary AF
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA functional class IV
- Left atrial area > 35 cm2
Show all 14Show fewer
- Uncorrected severe valvular heart disease
- Contraindication to anticoagulation
- Presence of left atrial thrombus
- Recent (<6 Months) myocardial Infarction or unstable angina or coronary artery by-pass
- Thoracic surgery for congenital, valvular or aortic disease
- History of cerebrovascular accidents
- Pregnancy
- Significant comorbidities such as cancer, severe renal insufficiency requiring hemodialysis, severe obstructive lung disease, cirrhosis, with a life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.
Read the detailed description
This study is a prospective, single center, randomized, single-blind, controlled, 2-arm parallel group trial in Milan, Italy.
The total duration of the study is expected to be 24 months with ~12 months of enrollment.
Approximately 80 subjects suffering from persistent AF will be randomized in a 1:1 fashion to the following investigation arms:
- Modified circumferential pulmonary vein ablation alone (mCPVA);
- Substrate-targeted ablation guided by AF substrate mapping, followed by completion of modified circumferential pulmonary vein ablation (Substrate+ mCPVA)
- Ablate the areas that have fast and regular electrical activities, starting from the fastest cycle length (defined by Mean CL in the range of 120-250 milliseconds, and SD CL in the range of 1-30 milliseconds
- Ablate the areas that have consistent rotational or focal propagation pattern (defined by conduction velocity vectors)
- Ablate the areas that comprises the slow conduction zone of possible arrhythmia circuits
- If AF terminates during RF ablation, stimulation protocol will be used to examine if AF is re-inducible. If AF sustains or is re-inducible and physician decides to remap, mapping will be performed again for substrate-targeted ablation. If AF is not re-inducible, mCPVA will be completed
Subjects will be followed up at 3, 6, 12 months.
The primary objective of the study is to assess acute and long-term outcome of patient-tailored substrate-targeted ablation (Substrate) plus modified circumferential pulmonary vein ablation (Substrate+mCPVA) versus modified circumferential pulmonary vein ablation alone (mCPVA). The secondary objective of the study is to map and characterize electrophysiological substrates during AF, including regular and fast activities, complex fractionated electrograms, wave front propagation directions, and fibrosis.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Substrate+mCPVA, mCPVA
- Keywords
- atrial fibrillation, mapping, substrate, 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.
Substrate+mCPVADevice
The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
mCPVADevice
The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
| Study group | Role | What they receive |
|---|---|---|
| mCPVA | Active comparator | Subjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF. Receives: Device: mCPVA |
| Substrate+mCPVA | Experimental | Subjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein ablation. Receives: Device: Substrate+mCPVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Clinical Success Rate
Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.
Measured: 12 months
Secondary outcomes (1)
Acute Ablation Procedure Outcome
Acute AF termination or significant AF cycle length slowing during RF application in ablation procedure
Measured: During Ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlo Pappone, MD, PhD, Principal investigator, I.R.C.C.S. Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571218
- Sponsor's protocol ID
- SJM-CIP-10054
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2015
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pappone C, Ciconte G, Vicedomini G, Mangual JO, Li W, Conti M, Giannelli L, Lipartiti F, McSpadden L, Ryu K, Guazzi M, Menicanti L, Santinelli V. Clinical Outcome of Electrophysiologically Guided Ablation for Nonparoxysmal Atrial Fibrillation Using a Novel Real-Time 3-Dimensional Mapping Technique: Results From a Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005904. doi: 10.1161/CIRCEP.117.005904.
PubMed 29535136
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate-Targeted Catheter Ablation to Treat Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02571218
- Acronym / sponsor ID
- SJM-CIP-10054
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- atrial fibrillation, mapping, substrate, ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.
Detailed description
This study is a prospective, single center, randomized, single-blind, controlled, 2-arm parallel group trial in Milan, Italy.
The total duration of the study is expected to be 24 months with ~12 months of enrollment.
Approximately 80 subjects suffering from persistent AF will be randomized in a 1:1 fashion to the following investigation arms:
- Modified circumferential pulmonary vein ablation alone (mCPVA);
- Substrate-targeted ablation guided by AF substrate mapping, followed by completion of modified circumferential pulmonary vein ablation (Substrate+ mCPVA)
- Ablate the areas that have fast and regular electrical activities, starting from the fastest cycle length (defined by Mean CL in the range of 120-250 milliseconds, and SD CL in the range of 1-30 milliseconds
- Ablate the areas that have consistent rotational or focal propagation pattern (defined by conduction velocity vectors)
- Ablate the areas that comprises the slow conduction zone of possible arrhythmia circuits
- If AF terminates during RF ablation, stimulation protocol will be used to examine if AF is re-inducible. If AF sustains or is re-inducible and physician decides to remap, mapping will be performed again for substrate-targeted ablation. If AF is not re-inducible, mCPVA will be completed
Subjects will be followed up at 3, 6, 12 months.
The primary objective of the study is to assess acute and long-term outcome of patient-tailored substrate-targeted ablation (Substrate) plus modified circumferential pulmonary vein ablation (Substrate+mCPVA) versus modified circumferential pulmonary vein ablation alone (mCPVA). The secondary objective of the study is to map and characterize electrophysiological substrates during AF, including regular and fast activities, complex fractionated electrograms, wave front propagation directions, and fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCPVA | Active comparator | Device: mCPVASubjects in the mCPVA arm will undergo intervention called "modified circumferential pulmonary vein ablation", which is considered to be the standard ablation treatment for AF. |
| Substrate+mCPVA | Experimental | Device: Substrate+mCPVASubjects in the Substrate+mCPVA arm will undergo intervention of substrate mapping and substrate-targeted ablation guided by the investigational device, followed by completion of modified circumferential pulmonary vein 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)
- 18 - 85 years of age
- Persistent AF scheduled to undergo catheter ablation with approved standard indication by ESC/EHRA guidelines
- First or second time ablation for persistent AF
- Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
Key exclusion criteria (14 listed)
- Had two or more previous AF ablation procedures
- Secondary AF
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA functional class IV
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 |
|---|---|---|
| Substrate+mCPVAThe intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation. | Device | Substrate+mCPVA |
| mCPVAThe intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation. | Device | mCPVA |
Primary outcome
Long-term Clinical Success Rate
Time frame: 12 months
Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.
1 secondary outcome
Acute Ablation Procedure Outcome
Time frame: During Ablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29535136Pappone C, Ciconte G, Vicedomini G, Mangual JO, Li W, Conti M, Giannelli L, Lipartiti F, McSpadden L, Ryu K, Guazzi M, Menicanti L, Santinelli V. Clinical Outcome of Electrophysiologically Guided Ablation for Nonparoxysmal Atrial Fibrillation Using a Novel Real-Time 3-Dimensional Mapping Technique: Results From a Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005904. doi: 10.1161/CIRCEP.117.005904.
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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.
Carlo Pappone, MD, PhD principal investigator
I.R.C.C.S. Policlinico San Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substrate+mCPVA and mCPVA in people with Persistent Atrial Fibrillation, run by Abbott Medical Devices at 1 site in Italy.
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 14 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 5 Jul 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 Italy. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Long-term Clinical Success Rate (time frame: 12 months). 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 NCT02571218, 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 5 Jul 2019.