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PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

Information source: Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Paroxysmal Atrial Fibrillation

Intervention: PVAI followed by adenosine provocation (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Texas Cardiac Arrhythmia Research Foundation

Official(s) and/or principal investigator(s):
Andrea Natale, MD, Principal Investigator, Affiliation: TCAI

Overall contact:
Andrea Natale, MD, Email: dr.natale@gmail.com

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.

Clinical Details

Official title: Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AF recurrence

Detailed description: Background: The efficiency of catheter ablation in drug-refractory atrial fibrillation (AF) is compromised by high incidence of post-ablation AF recurrences requiring multiple ablation procedures (1). Post-PVAI (pulmonary vein antrum isolation) AF recurrence is mostly due to reconnection of the previously isolated PVs (2). Earlier studies have revealed that elimination of dormant PV conduction revealed by adenosine-provocation ensures better outcome as reconnection mostly happens due to presence of incompletely ablated tissue and identification and complete ablation decrease chance of recurrence (1). Adenosine is specifically chosen for induction of triggers because it is known to transiently or permanently re-establish left atrium-pulmonary vein (LA-PV) conduction after apparently successful PV isolation (3). Datino et al have demonstrated in the canines that adenosine selectively hyperpolarizes the PVs by increasing inward rectifier potassium (K+) current and restores excitability (4). As incompletely ablated tissue can potentially cause AF recurrence, the depth and extension of the lesion are crucial factors in determining the success-rate of ablation; these in turn are directly influenced by catheter type and the radio-frequency (RF) energy settings (5). In a previous study, Matiello et al have reported cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that with 30w setting (5). However, none of the earlier studies have examined the rate of PV reconnection when AF ablation is done at different power settings using open-irrigated catheters after the dormant sites are revealed by adenosine-challenge. Hypothesis: Use of higher wattage during ablation before and after adenosine-challenge is associated with lower rate of PV reconnection.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Andrea Natale, MD, Email: dr.natale@gmail.com

St. david's Medical Center, Austin, Texas 78705, United States; Not yet recruiting
Luigi Di Biase, MD PhD, Email: dibbia@gmail.com
Mitra Mohanty, MD, Email: mitra1989@gmail.com

Texas Cardiac arrhythmia Institute, St. David's Hospital, Austin, Texas 78705, United States; Recruiting
Andrea Natale, MD, Phone: 512-544-8186, Email: dr.natale@gmail.com

Additional Information

Starting date: May 2013
Last updated: May 19, 2015

Page last updated: August 20, 2015

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