Characterization and Elimination of Mother Rotors

NCT01924377 | Withdrawn DMC

• 1 other identifier: MCH-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

AF

Outcome Measures

Primary Outcomes (1)

• freedom from symptomatic AF, atrial tachycardia, and atrial flutter

  documented by implantable loop recorder monitoring or trans-telephonic (TT) ECG monitoring

  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

  from the end of the 3 months blanking period to 12 months following the ablation procedure

• One year clinical/partial success rate

  12 months following the ablation procedure

• Number of Rotors electrograms

  at time of pre-ablation electrophysiological mapping

• anatomical locations of Rotors electrograms

  at time of pre-ablation electrophysiological mapping

• characteristics of Rotors electrograms

  at time of pre-ablation electrophysiological mapping

Other Outcomes (1)

• a potential relationship between baseline AF burden, number of rotors and outcome

  up to 12 months following the ablation procedure

Study Arms (2)

standard circumferential pulmonary vein isolation (CPVI)

OTHER

standard circumferential pulmonary vein isolation by radiofrequenvy ablation

Procedure: standard circumferential pulmonary vein isolation by radiofrequency ablation catheter

CPVI + Rotor

EXPERIMENTAL

standard circumferential pulmonary vein isolation + rotors' identification and ablation'

Procedure: CPVI + rotors' identification and ablation

Interventions

standard circumferential pulmonary vein isolation by radiofrequency ablation catheter PROCEDURE

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.

Also known as: Any commercially available Radiofrequency ablation system;, Any commercially available irrigated tip RF ablation catheter (minimum 4 electrodes);

standard circumferential pulmonary vein isolation (CPVI)

CPVI + rotors' identification and ablation PROCEDURE

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.

CPVI + Rotor

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Cecilia Hospital: lead
• Ettore Sansavini Health Science Foundation: collaborator
• Mediolanum Cardio Research: collaborator

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Pappone, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 16, 2013
• Study Start: May 28, 2013
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

IT (1)