- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672346
PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation (ZODIAC)
Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Luigi Di Biase, MD
- Email: dibbia@gmail.com
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Recruiting
- Texas Cardiac arrhythmia Institute, St. David's Hospital
-
Austin, Texas, United States, 78705
- Not yet recruiting
- St. David's Medical Center
-
Contact:
- Luigi Di Biase, MD PhD
- Email: dibbia@gmail.com
-
Contact:
- Mitra Mohanty, MD
- Email: mitra1989@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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).
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AF recurrence
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
Other Study ID Numbers
- ZODIAC_TCAI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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