PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation (ZODIAC)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PVAI followed by adenosine provocation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring PAF
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patients presenting with drug-refractory PAF undergoing first ablation
- 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
Sites / Locations
- St. david's Medical Center
- Texas Cardiac arrhythmia Institute, St. David's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm I
Arm II
Arm Description
PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge
AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01672346
First Posted
August 21, 2012
Last Updated
April 8, 2019
Sponsor
Texas Cardiac Arrhythmia Research Foundation
Collaborators
California Pacific Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01672346
Brief Title
PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation
Acronym
ZODIAC
Official Title
Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
Collaborators
California Pacific Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
PAF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge
Intervention Type
Procedure
Intervention Name(s)
PVAI followed by adenosine provocation
Intervention Description
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 Information:
Title
AF recurrence
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patients presenting with drug-refractory PAF undergoing first ablation
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natale, MD
Email
dr.natale@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Di Biase, MD
Email
dibbia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
TCAI
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. david's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Di Biase, MD PhD
Email
dibbia@gmail.com
First Name & Middle Initial & Last Name & Degree
Mitra Mohanty, MD
Email
mitra1989@gmail.com
Facility Name
Texas Cardiac arrhythmia Institute, St. David's Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Phone
512-544-8186
Email
dr.natale@gmail.com
12. IPD Sharing Statement
Learn more about this trial
PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation
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