Characterization and Elimination of Mother Rotors (CENTRA-AF)
Primary Purpose
Atrial Fibrillation
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
standard circumferential pulmonary vein isolation by radiofrequency ablation catheter
CPVI + rotors' identification and ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous AF ablation
- Secondary AF
- Hyperthyroidism
- Left ventricular ejection fraction <30%
- NYHA functional class IV
- Left atrial area > 35 cm2
- 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.
Sites / Locations
- Maria Cecilia Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
standard circumferential pulmonary vein isolation (CPVI)
CPVI + Rotor
Arm Description
standard circumferential pulmonary vein isolation by radiofrequenvy ablation
standard circumferential pulmonary vein isolation + rotors' identification and ablation'
Outcomes
Primary Outcome Measures
freedom from symptomatic AF, atrial tachycardia, and atrial flutter
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
Secondary Outcome Measures
Freedom from asymptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
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
Number of Rotors electrograms
anatomical locations of Rotors electrograms
characteristics of Rotors electrograms
Amplitude and cycle lenght of Rotors electrograms
Full Information
NCT ID
NCT01924377
First Posted
August 2, 2013
Last Updated
July 25, 2018
Sponsor
Maria Cecilia Hospital
Collaborators
Ettore Sansavini Health Science Foundation, Mediolanum Cardio Research
1. Study Identification
Unique Protocol Identification Number
NCT01924377
Brief Title
Characterization and Elimination of Mother Rotors
Acronym
CENTRA-AF
Official Title
Characterization and Elimination of Mother Rotors - A Mechanism-targeted Approach for Catheter Ablation of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI changed work place
Study Start Date
May 28, 2013 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Cecilia Hospital
Collaborators
Ettore Sansavini Health Science Foundation, Mediolanum Cardio Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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:
i) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
AF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard circumferential pulmonary vein isolation (CPVI)
Arm Type
Other
Arm Description
standard circumferential pulmonary vein isolation by radiofrequenvy ablation
Arm Title
CPVI + Rotor
Arm Type
Experimental
Arm Description
standard circumferential pulmonary vein isolation + rotors' identification and ablation'
Intervention Type
Procedure
Intervention Name(s)
standard circumferential pulmonary vein isolation by radiofrequency ablation catheter
Other Intervention Name(s)
Any commercially available Radiofrequency ablation system;, Any commercially available irrigated tip RF ablation catheter (minimum 4 electrodes);
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CPVI + rotors' identification and ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
freedom from symptomatic AF, atrial tachycardia, and atrial flutter
Description
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
Time Frame
from the end of the 3 months blanking period to 12 months following the ablation proce
Secondary Outcome Measure Information:
Title
Freedom from asymptomatic AF, atrial tachycardia, and atrial flutter off antiarrhythmic drug
Description
documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring
Time Frame
from the end of the 3 months blanking period to 12 months following the ablation procedure
Title
One year clinical/partial success rate
Description
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
Time Frame
12 months following the ablation procedure
Title
Number of Rotors electrograms
Time Frame
at time of pre-ablation electrophysiological mapping
Title
anatomical locations of Rotors electrograms
Time Frame
at time of pre-ablation electrophysiological mapping
Title
characteristics of Rotors electrograms
Description
Amplitude and cycle lenght of Rotors electrograms
Time Frame
at time of pre-ablation electrophysiological mapping
Other Pre-specified Outcome Measures:
Title
a potential relationship between baseline AF burden, number of rotors and outcome
Time Frame
up to 12 months following the ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Previous AF ablation
Secondary AF
Hyperthyroidism
Left ventricular ejection fraction <30%
NYHA functional class IV
Left atrial area > 35 cm2
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD
Organizational Affiliation
Maria Cecilia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Hospital
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48010
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Characterization and Elimination of Mother Rotors
We'll reach out to this number within 24 hrs