NCT02571218

Brief 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 long-term success of conventional catheter ablation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

July 27, 2015

Results QC Date

April 3, 2018

Last Update Submit

April 16, 2019

Conditions

Persistent Atrial Fibrillation

Keywords

atrial fibrillationmappingsubstrateablation

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Acute Ablation Procedure Outcome

    During Ablation

Study Arms (2)

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.

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.

Device: Substrate+mCPVA

Interventions

Substrate+mCPVADEVICE

The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.

Substrate+mCPVA
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.

mCPVA

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (1)

  • 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.

    PMID: 29535136DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Giuseppe Ciconte
Organization
IRCCS Policlinico San Donato
g.ciconte@gmail.com
+39 02 52 77 42 60

Study Officials

  • Carlo Pappone, MD, PhD

    I.R.C.C.S. Policlinico San Donato

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

October 8, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Locations

IT(1)