Atrial FibrillationCENTRA-AFNCT01924377
Characterization and Elimination of Mother Rotors
A study testing standard circumferential pulmonary vein isolation by radiofrequency ablation catheter and CPVI + rotors' identification and ablation in people with Atrial Fibrillation, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained by localized sources called "mother rotors" which exhibit persistent, fast, and well organized activity during AF and play an important role in the generation and maintenance of the fibrillatory activity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- standard circumferential pulmonary vein isolation by radiofrequency ablation catheter and CPVI + rotors' identification and ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2013to 25 Jul 2018
- 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
- Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure
- Age between 18 and 85 years
- Ability to provide informed consent for study participation and be willing and able to comply with study evaluations and follow-up schedule
- AF burden equal to or greater than 24 hours in the screening period before enrollment
Who cannot join
- Previous AF ablation
- Secondary AF
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA functional class IV
- Left atrial area > 35 cm2
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- 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 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization and Elimination of Mother Rotors - A Mechanism-targeted Approach for Catheter Ablation of Atrial Fibrillation
Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained by localized sources called "mother rotors" which exhibit persistent, fast, and well organized activity during AF and play an important role in the generation and maintenance of the fibrillatory activity. In this study, investigators aim to identify the electrophysiological characteristics of mother rotors during atrial fibrillation in patients with paroxysmal and 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
The present study is designed as a prospective, single-centre, randomized, single-blind, controlled, 2-arm parallel group trial.
The study will consist of:
- a two-month screening period; ii) randomization and treatment phase; iii) a follow-up phase lasting up to 24 months. Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure will be screened. It is expected that approximately 260 patients will be screened in order to have 234 patients fulfilling inclusion criteria at the end of the screening period. The sample will include 154 patients with paroxysmal AF and 80 patients with persistent AF. Paroxysmal and persistent AF will be defined according to current ESC guidelines.
Patients fulfilling selection criteria, will be informed of the study and asked for participation. The study requirements, including required testing, will be discussed with the subject. A signed Informed Consent Form for study participation must be obtained prior to any study-related procedure. Patients will be given a daily diary for recording AF-related signs and symptoms and instructed to bring it back at the inclusion visit.
Eligible patients will be randomised using a web-based randomization system embedded in the electronic CRF (e-CRF).
A randomization schedule, stratified by AF type, using balanced blocks will be established before the start of the trial.
Patients will be randomised to one of the two ablation procedures:
- standard circumferential pulmonary vein isolation (CPVI)
- CPVI followed by rotors' identification and ablation (CPVI + Rotor.
The acute endpoint for AF ablation procedure is electrical isolation of the pulmonary veins and non inducibility of AF by atrial extrastimuli.
Rotors are defined as fast and persistent electrical activation with intracardiac electrograms of regular cycle lengths shorter than 240 ms with stable isoelectric line between two adjacent activation.
The acute endpoints for rotors are their identification by predefined mapping characteristics and their elimination by radiofrequency ablation after circumferential pulmonary vein isolation.
Antiarrhythmic medications may be continued for the first 3 months following the first ablation to avoid early recurrences. At 3 months, antiarrhythmics must be stopped to assess for clinical recurrence.
Freedom from symptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug therapy as assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, and documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring.
AF episodes > 10 minutes documented by implantable loop recorder registrations or daily trans-telephonic (TT) ECG will be recorded in the e-CRF, clearly identified by date and time of occurrence. Total duration of the episode will also be recorded. In addition, presence of symptoms, as reported by the patient in the daily diary will be sought.
A Clinical Events Committee (CEC) made up of three cardiologists and arrhythmologists who are not participants in the study will review and adjudicate, symptomatic and asymptomatic AF recurrences.
The Clinical Research Unit staff will support the Investigator and the Sponsor to maintain a high level of ethical, scientific, technical and regulatory quality in all aspects of the Clinical Trial. At regular intervals during the Clinical Trial, the Clinical Research Unit staff will review study progress and any emergent problems. Random source data verification will be performed.
Data will be collected by means of an electronic e-CRF, FDA 21 CFR part 11 compliant.
A detailed Statistical Analysis Plan will be issued.
- Conditions
- Atrial Fibrillation
- Being tested
- standard circumferential pulmonary vein isolation by radiofrequency ablation catheter, CPVI + rotors' identification and ablation
- Keywords
- AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard circumferential pulmonary vein isolation by radiofrequency ablation catheterProcedure or surgery
Also called Any commercially available Radiofrequency ablation system;, Any commercially available irrigated tip RF ablation catheter (minimum 4 electrodes);
To perform circumferential pulmonary vein isolation left and right circumferential lines will be created with contiguous focal radiofrequency lesions at a distance >5 mm from the pulmonary vein ostia. Two additional ablation lines will be performed in the posterior left atrium (LA), and an ablation line will be placed in the mitral isthmus to prevent postablation LA flutter. Patients with a history of typical atrial flutter will also undergo cavotricuspid isthmus ablation.
CPVI + rotors' identification and ablationProcedure or surgery
In CPVI + Rotor arm, two LA sequential maps will be collected before and after CPVI, respectively. During each map creation, rotor electrograms will be identified by the physician. Rotors will be ablated after collecting the second LA sequential map.
| Study group | Role | What they receive |
|---|---|---|
| standard circumferential pulmonary vein isolation (CPVI) | Other | standard circumferential pulmonary vein isolation by radiofrequenvy ablation Receives: Procedure: standard circumferential pulmonary vein isolation by radiofrequency ablation catheter |
| CPVI + Rotor | Experimental | standard circumferential pulmonary vein isolation + rotors' identification and ablation' Receives: Procedure: CPVI + rotors' identification and ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from symptomatic AF, atrial tachycardia, and atrial flutter
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
Measured: from the end of the 3 months blanking period to 12 months following the ablation proce
Secondary outcomes (5)
Freedom from asymptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
Measured: from the end of the 3 months blanking period to 12 months following the ablation procedure
One year clinical/partial success rate
defined as a 75% or greater reduction in the number of AF episodes, the duration of AF episodes, or the % time a patient is in AF as assessed with by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring measuring AF burden, in the presence or absence of previously ineffective antiarrhythmic drug therapy
Measured: 12 months following the ablation procedure
Number of Rotors electrograms
Measured: at time of pre-ablation electrophysiological mapping
anatomical locations of Rotors electrograms
Measured: at time of pre-ablation electrophysiological mapping
characteristics of Rotors electrograms
Amplitude and cycle lenght of Rotors electrograms
Measured: at time of pre-ablation electrophysiological mapping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study start28 May 2013
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Why it stopped: PI changed work place
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation, Mediolanum Cardio Research
- Responsible party
- Sponsor
- Investigators
- Carlo Pappone, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924377
- Sponsor's protocol ID
- MCH-01
- Acronym
- CENTRA-AF
- Status last verified
- Jul 2018
- First submitted
- 2 Aug 2013
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Elimination of Mother Rotors - A Mechanism-targeted Approach for Catheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01924377
- Acronym / sponsor ID
- CENTRA-AF / MCH-01
- Conditions
- Atrial Fibrillation
- Keywords
- AF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI changed work place
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation, Mediolanum Cardio Research
- Study start
- 28 May 2013 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 16 Aug 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.
Recent clinical studies have shown that atrial fibrillation (AF) in humans might be sustained by localized sources called "mother rotors" which exhibit persistent, fast, and well organized activity during AF and play an important role in the generation and maintenance of the fibrillatory activity. In this study, investigators aim to identify the electrophysiological characteristics of mother rotors during atrial fibrillation in patients with paroxysmal and 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
The present study is designed as a prospective, single-centre, randomized, single-blind, controlled, 2-arm parallel group trial.
The study will consist of:
- a two-month screening period; ii) randomization and treatment phase; iii) a follow-up phase lasting up to 24 months. Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure will be screened. It is expected that approximately 260 patients will be screened in order to have 234 patients fulfilling inclusion criteria at the end of the screening period. The sample will include 154 patients with paroxysmal AF and 80 patients with persistent AF. Paroxysmal and persistent AF will be defined according to current ESC guidelines.
Patients fulfilling selection criteria, will be informed of the study and asked for participation. The study requirements, including required testing, will be discussed with the subject. A signed Informed Consent Form for study participation must be obtained prior to any study-related procedure. Patients will be given a daily diary for recording AF-related signs and symptoms and instructed to bring it back at the inclusion visit.
Eligible patients will be randomised using a web-based randomization system embedded in the electronic CRF (e-CRF).
A randomization schedule, stratified by AF type, using balanced blocks will be established before the start of the trial.
Patients will be randomised to one of the two ablation procedures:
- standard circumferential pulmonary vein isolation (CPVI)
- CPVI followed by rotors' identification and ablation (CPVI + Rotor.
The acute endpoint for AF ablation procedure is electrical isolation of the pulmonary veins and non inducibility of AF by atrial extrastimuli.
Rotors are defined as fast and persistent electrical activation with intracardiac electrograms of regular cycle lengths shorter than 240 ms with stable isoelectric line between two adjacent activation.
The acute endpoints for rotors are their identification by predefined mapping characteristics and their elimination by radiofrequency ablation after circumferential pulmonary vein isolation.
Antiarrhythmic medications may be continued for the first 3 months following the first ablation to avoid early recurrences. At 3 months, antiarrhythmics must be stopped to assess for clinical recurrence.
Freedom from symptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug therapy as assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, and documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring.
AF episodes > 10 minutes documented by implantable loop recorder registrations or daily trans-telephonic (TT) ECG will be recorded in the e-CRF, clearly identified by date and time of occurrence. Total duration of the episode will also be recorded. In addition, presence of symptoms, as reported by the patient in the daily diary will be sought.
A Clinical Events Committee (CEC) made up of three cardiologists and arrhythmologists who are not participants in the study will review and adjudicate, symptomatic and asymptomatic AF recurrences.
The Clinical Research Unit staff will support the Investigator and the Sponsor to maintain a high level of ethical, scientific, technical and regulatory quality in all aspects of the Clinical Trial. At regular intervals during the Clinical Trial, the Clinical Research Unit staff will review study progress and any emergent problems. Random source data verification will be performed.
Data will be collected by means of an electronic e-CRF, FDA 21 CFR part 11 compliant.
A detailed Statistical Analysis Plan will be issued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard circumferential pulmonary vein isolation (CPVI) | Other | Procedure: standard circumferential pulmonary vein isolation by radiofrequency ablation catheterstandard circumferential pulmonary vein isolation by radiofrequenvy ablation |
| CPVI + Rotor | Experimental | Procedure: CPVI + rotors' identification and ablationstandard circumferential pulmonary vein isolation + rotors' identification and 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)
- Patients with paroxysmal or persistent atrial fibrillation referred to the centre to undergo catheter ablation procedure
- Age between 18 and 85 years
- Ability to provide informed consent for study participation and be willing and able to comply with study evaluations and follow-up schedule
- AF burden equal to or greater than 24 hours in the screening period before enrollment
Key exclusion criteria (14 listed)
- Previous AF ablation
- 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 |
|---|---|---|
| standard circumferential pulmonary vein isolation by radiofrequency ablation catheterAlso: Any commercially available Radiofrequency ablation system;, Any commercially available irrigated tip RF ablation catheter (minimum 4 electrodes);To perform circumferential pulmonary vein isolation left and right circumferential lines will be created with contiguous focal radiofrequency lesions at a distance >5 mm from the pulmonary vein ostia. Two additional ablation lines will be performed in the posterior left atrium (LA), and an ablation line will be placed in the mitral isthmus to prevent postablation LA flutter. Patients with a history of typical atrial flutter will also undergo cavotricuspid isthmus ablation. | Procedure or surgery | standard circumferential pulmonary vein isolation (CPVI) |
| CPVI + rotors' identification and ablationIn CPVI + Rotor arm, two LA sequential maps will be collected before and after CPVI, respectively. During each map creation, rotor electrograms will be identified by the physician. Rotors will be ablated after collecting the second LA sequential map. | Procedure or surgery | CPVI + Rotor |
Primary outcome
freedom from symptomatic AF, atrial tachycardia, and atrial flutter
Time frame: from the end of the 3 months blanking period to 12 months following the ablation proce
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
5 secondary outcomes
Freedom from asymptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug
Time frame: from the end of the 3 months blanking period to 12 months following the ablation procedure
One year clinical/partial success rate
Time frame: 12 months following the ablation procedure
Number of Rotors electrograms
Time frame: at time of pre-ablation electrophysiological mapping
anatomical locations of Rotors electrograms
Time frame: at time of pre-ablation electrophysiological mapping
characteristics of Rotors electrograms
Time frame: at time of pre-ablation electrophysiological mapping
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
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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 principal investigator
Maria Cecilia 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 standard circumferential pulmonary vein isolation by radiofrequency ablation catheter and CPVI + rotors' identification and ablation in people with Atrial Fibrillation, run by Maria Cecilia Hospital 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: withdrawn, as of the sponsor's last update on 27 Jul 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
freedom from symptomatic AF, atrial tachycardia, and atrial flutter (time frame: from the end of the 3 months blanking period to 12 months following the ablation proce). 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 27 Jul 2018.