Recruiting
Phase 3

PVAI

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

Code:

NCT01672346

Conditions

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

PVAI followed by adenosine provocation

Study Details

Brief summary:

In this prospective randomized study, we aim to compare the rate of PV reconnection following PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV conduction will be unmasked by adenosine-provocation.

Conditions

Paroxysmal Atrial Fibrillation

Study ID

NCT01672346

Start date

May, 2013

Status verified date

Apr, 2019

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 presenting with drug-refractory PAF undergoing first ablation
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

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I

PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge

active comparator: Arm II

AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge

Interventions

PVAI followed by adenosine provocation

All patients will undergo PVAI and ablation of the posterior wall of the LA using an open-irrigated ablation catheter and under general anesthesia. After PV isolation is achieved, all will undergo PVAI followed by adenosine provocation test with 24 mg of adenosine to check for PV reconnection. Upon identification, additional RF energy would be used to ablate those sites (that were revealed by adenosine-provocation).

Primary outcome measure

  • AF recurrence [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Andrea Natale, MD

dr.natale@gmail.com

Luigi Di Biase, MD

dibbia@gmail.com

Locations

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

Apr 10, 2019

Last verified

Apr, 2019

Keywords

  • PAF

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 2019-04-10.