Recruiting

PVAI & Scar Homogenization

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT01672138

Conditions

Persistent Atrial Fibrillation

Long-standing Persistent Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulmonary Vein Antrum Isolation

scar homogenization

Non-PV triggers ablation

Study Details

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\]

Conditions

Persistent Atrial Fibrillation

Long-standing Persistent Atrial Fibrillation

Study ID

NCT01672138

Start date

Feb, 2013

Status verified date

Nov, 2018

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall

active comparator: Study I

PVAI+ scar homogenization

active comparator: Study II

PVAI + isolation of left atrial posterior wall + non-PV triggers ablation

Interventions

Pulmonary Vein Antrum Isolation

Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall

scar homogenization

PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.

Non-PV triggers ablation

PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites

Primary outcome measure

  • Recurrence of atrial arrhythmia [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Andrea Natale, MD

dr.natale@gmail.com

Mitra Mohanty, MD

mitra.mohanty@stdavids.com

Locations

St. david's medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Mitra Mohanty, MD

512-544-8198mitra1989@gmail.com

mitra1989@gmail.com

Texas Cardiac arrhythmia Institute, St. David's Hospital

Recruiting

Austin, Texas, United States, 78705

Contacts

Andrea Natale, MD

512-544-8186dr.natale@gmail.com

More Information

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Last update posted

Nov 16, 2018

Last verified

Nov, 2018

Keywords

  • PVAI
  • NPAF
  • Non-PV triggers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation on 2018-11-16.