Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogeni... | NCT01672138

Studies
Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

NCT01672138

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Status

Unknown status

Last Update Posted

Nov 16, 2018Actual

Enrollment

186Estimated

Phase

Not Applicable

Conditions

Persistent Atrial Fibrillation
Long-standing Persistent Atrial Fibrillation

Interventions

Pulmonary Vein Antrum Isolation
scar homogenization
Non-PV triggers ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 21, 2012

First Submission Date that Met QC Criteria

Aug 21, 2012

First Posted Date

Aug 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2018

Last Update Posted Date

Nov 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Natale, Executive medical director, TCAI, Texas Cardiac Arrhythmia Research FoundationPrincipal Investigator

Lead Sponsor

Texas Cardiac Arrhythmia Research FoundationOTHER

Collaborators

Name	Class
RCCS Monzino Hospital, Milan, Italy	UNKNOWN
Ospedale dell'Angelo, Venezia-Mestre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers [ PVAI: Pulmonary Vein Antrum Isolation

Non-PV triggers: Triggers arising from sites other than pulmonary veins]

Detailed Description

Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations.

Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall	Procedure: Pulmonary Vein Antrum Isolation
Study I	Active Comparator	PVAI+ scar homogenization	Procedure: Pulmonary Vein Antrum Isolation Procedure: scar homogenization
Study II	Active Comparator	PVAI + isolation of left atrial posterior wall + non-PV triggers ablation	Procedure: Pulmonary Vein Antrum Isolation Procedure: scar homogenization Procedure: Non-PV triggers ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary Vein Antrum Isolation	Procedure	Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall	Control Study I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of atrial arrhythmia	Any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence). Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Improvement in quality of life	Improvement in quality of life	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
Ability to understand and provide signed informed consent

Exclusion Criteria:

Previous catheter ablation or MAZE procedure in left atrium
Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Natale, MD	Contact			dr.natale@gmail.com
Mitra Mohanty, MD	Contact			mitra.mohanty@stdavids.com

Overall Officials

Name	Affiliation	Role
Andrea Natale, MD	TCAI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. david's medical Center	Recruiting	Austin	Texas	78705	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms