CClinicalTrials.gg
Status unknownNCT01672346ZODIACUpdated Apr 10, 2019

PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation

A Phase 3 interventional study of PVAI followed by adenosine provocation in Paroxysmal Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Texas Cardiac Arrhythmia Research Foundation · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Paroxysmal Atrial Fibrillation

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Keywords

  • PAF
03

In context

Atrial Fibrillation

3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's planned enrollment of 188 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (estimated)

Study 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

    Procedure: PVAI followed by adenosine provocation

  • 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

    Procedure: PVAI followed by adenosine provocation

Interventions

  • ProcedurePVAI 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).

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What researchers measure

Primary outcomes

  1. AF recurrence

    Recurrence of AF due to PV reconnection AF recurrence is defined as 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.

    Time frame: 1 year

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Study locations

1 of 2 sites recruiting
  • St. david's Medical Center
    Austin, Texas 78705, United States
    Not yet recruiting
  • Texas Cardiac arrhythmia Institute, St. David's Hospital
    Austin, Texas 78705, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01672346
Lead sponsor
Texas Cardiac Arrhythmia Research Foundation
Collaborators
California Pacific Medical Center
Responsible party
Andrea Natale (Executive medical director, TCAI, Texas Cardiac Arrhythmia Research Foundation) — Principal investigator
First posted
Aug 24, 2012
Start date
May 2013
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Apr 10, 2019

Study contacts

Andrea Natale, MD
Contact
dr.natale@gmail.com
Luigi Di Biase, MD
Contact
dibbia@gmail.com
Andrea Natale, MD
principal investigator · TCAI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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