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Effectiveness Study of Circumferential vs. Segmental Ablation in Paroxysmal Atrial Fibrillation (PAF)

Primary Purpose

Paroxysmal Atrial Fibrillation, Atrial Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circumferential Pulmonary Vein Ablation
Segmental Pulmonary Vein Isolation
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal atrial fibrillation, PAF, arrhythmia, atrial fibrillation ablation, circumferential ablation, CPVA, segmental ablation, PVI, pulmonary vein isolation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with paroxysmal atrial fibrillation, whose episodes have never been documented to exceed 48 hours duration
  2. Patients with a clinical indication for ablation
  3. Patients greater than 18 years of age.
  4. Patients willing and able to give informed consent.
  5. Patients with concurrent atrial fibrillation and atrial flutter are allowed.

Exclusion Criteria:

  1. Patients with medical conditions that would limit participation for the entire duration of the study.
  2. Patients that are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment).
  3. Patients having undergone prior AF ablation
  4. Patients with paroxysmal atrial fibrillation whose episodes last greater than 48 hours
  5. Patients with persistent AF

Sites / Locations

  • UCSD Sulpizio Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Circumferential Pulmonary Vein Ablation

Segmental Pulmonary Vein Isolation

Arm Description

Contiguous ablation lesions will be performed to encircle the two left and right pulmonary veins (PVs), guided by 3D electroanatomic mapping (Carto, Biosense Webster, Inc. or ESI NavX, St. Jude, Inc.) with a 3D LA geometry created either by using the roving mapping catheter or by importing a pre-recorded 3D CT image of the left atrium. After completion of the circumferential ablation, PV isolation will be confirmed by the mapping catheter, and further focal ablation performed as required until electrical PV isolation is confirmed (entrance block at a minimum).

Electrical potentials recorded in the pulmonary vein (PV) ostium using a circular mapping catheter, representing myocardial connections between the left atrium and PVs will be ablated at or just proximal to the PV ostium in the PV antrum. Ablation will be performed segmentally at multiple sites guided by the mapping catheter around the PV ostium or antrum, until mapping demonstrates elimination of all PV potentials (entrance block at a minimum).

Outcomes

Primary Outcome Measures

Atrial Fibrillation Recurrence
Recurrence of atrial fibrillation (AF) will be defined as any ECG documented symptomatic AF, or asymptomatic AF lasting >30 seconds on Mobile Outpatient Cardiac Telemetry (MCOT) monitoring. Subjects will be scheduled for clinic visits at 1, 6, 12 and 24 months post ablation. In addition, mobile outpatient telemetry will be performed for at least seven days at 6, 12 and 24 months post-procedure to detect recurrence of asymptomatic atrial fibrillation.

Secondary Outcome Measures

Pulmonary Vein Stenosis
A CT scan of the left atrium and pulmonary veins will be routinely performed 3 months after ablation to assess for any evidence of pulmonary vein stenosis

Full Information

First Posted
April 3, 2014
Last Updated
May 20, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02106663
Brief Title
Effectiveness Study of Circumferential vs. Segmental Ablation in Paroxysmal Atrial Fibrillation
Acronym
PAF
Official Title
Evaluating the Efficacy of Circumferential Pulmonary Vein Ablation (CPVA) Versus Segmental Pulmonary Vein Isolation (SPVI) in Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a PI-initiated study that aims to evaluate the efficacy of two different methods of paroxysmal atrial fibrillation (PAF) ablation. There are currently two strategies for PAF ablation that are routinely performed by electrophysiology clinicians: (1) circumferential pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). However, it is not known if one approach is better than the other. This randomized study will evaluate and compare the efficacy of CPVA versus SPVI in subjects undergoing ablation for paroxysmal atrial fibrillation only. Subjects will have a 50/50 chance of receiving either the CPVA or SPVI ablation method.
Detailed Description
Despite more than a decade of clinical experience and investigation, the optimal approach to ablation of paroxysmal atrial fibrillation (PAF) still remains controversial. There are currently two strategies for ablation of PAF: (1) circumferential pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). There are advantages and disadvantages associated with each method. In the CPVA method (1), contiguous ablation lesions are created to encircle the two left and right pulmonary veins (PVs), guided by a three-dimensional (3D) electroanatomic mapping system (Carto, Biosense Webster, Inc. or ESI NavX, St. Jude, Inc.) with a 3D left atrial (LA) geometry created either by using the mapping catheter or by importing a pre-recorded 3D computed tomography (CT) image. In the SPVI method (2), electrical potentials recorded at the PV ostium, that represent myocardial connections between the LA and PVs, are ablated at the PV ostium or just proximal to the PV ostium in the PV antrum. In this approach, ablation is performed segmentally at multiple sites around the PV ostium or antrum, until mapping with a circular catheter demonstrates pulmonary vein isolation. The reported success rates for SPVI for prevention of recurrence of PAF range from 60-87% (2-4) with most recurrences associated with recovery of PV conduction. Therefore, the success of SPVI for treatment of PAF appears to be related to in large part to permanent elimination of the triggers of AF. In a retrospective study by Sawhney et al, overall 5-year outcome after SPVI for PAF was similar to that for short-term follow up less than or equal to 2 years. However, late recurrences after 2 years did occur (up to 22.5%) and repeat ablation was often required to maintain freedom from symptomatic PAF (5). Even though success rates for CPVA have been reported to be higher (up to 90%), most CPVA procedures previously reported included left atrial linear ablation (LALA), additional ablation lesions or lines connecting the mitral valve to the posterior pulmonary veins or along the roof of the left atrium. Thus the success of CPVA may be due in part to ablation of substantially larger amounts of atrial tissue (6-7). However, additional ablation (LALA) may cause potential pro-arrhythmic effects that lead to development of atypical left atrial flutter (8). Compared to SPVI, CPVA resulted in higher success rates and lower fluoroscopy time in one study by Arentz et al (9). However, that study included subjects with both PAF and persistent AF, and those with persistent AF have potentially different underlying mechanisms. Furthermore, two other randomized studies comparing the efficacy of PVI and CPVA have shown conflicting results (10-11). Thus, we will initiate this randomized controlled study to evaluate the efficacy of CPVA versus SPVI in subjects undergoing ablation of paroxysmal atrial fibrillation only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
Keywords
atrial fibrillation, paroxysmal atrial fibrillation, PAF, arrhythmia, atrial fibrillation ablation, circumferential ablation, CPVA, segmental ablation, PVI, pulmonary vein isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circumferential Pulmonary Vein Ablation
Arm Type
Active Comparator
Arm Description
Contiguous ablation lesions will be performed to encircle the two left and right pulmonary veins (PVs), guided by 3D electroanatomic mapping (Carto, Biosense Webster, Inc. or ESI NavX, St. Jude, Inc.) with a 3D LA geometry created either by using the roving mapping catheter or by importing a pre-recorded 3D CT image of the left atrium. After completion of the circumferential ablation, PV isolation will be confirmed by the mapping catheter, and further focal ablation performed as required until electrical PV isolation is confirmed (entrance block at a minimum).
Arm Title
Segmental Pulmonary Vein Isolation
Arm Type
Active Comparator
Arm Description
Electrical potentials recorded in the pulmonary vein (PV) ostium using a circular mapping catheter, representing myocardial connections between the left atrium and PVs will be ablated at or just proximal to the PV ostium in the PV antrum. Ablation will be performed segmentally at multiple sites guided by the mapping catheter around the PV ostium or antrum, until mapping demonstrates elimination of all PV potentials (entrance block at a minimum).
Intervention Type
Procedure
Intervention Name(s)
Circumferential Pulmonary Vein Ablation
Other Intervention Name(s)
radiofrequency catheter ablation, atrial fibrillation ablation
Intervention Description
Contiguous ablation lesions will be performed to encircle the two left and right pulmonary veins (PVs) of the left atrium, guided by 3D electroanatomic mapping. After completion of the circumferential ablation, PV isolation will be confirmed by the mapping catheter, and further focal ablation performed as required until electrical PV isolation is confirmed.
Intervention Type
Procedure
Intervention Name(s)
Segmental Pulmonary Vein Isolation
Other Intervention Name(s)
radiofrequency catheter ablation, atrial fibrillation ablation
Intervention Description
Electrical potentials recorded in the pulmonary vein (PV) ostium using a circular mapping catheter, representing electrical connections between the left atrium and PVs will be ablated at or just proximal to the PV ostium in the PV antrum. Ablation will be performed segmentally at multiple sites guided by the mapping catheter until mapping demonstrates elimination of all PV potentials.
Primary Outcome Measure Information:
Title
Atrial Fibrillation Recurrence
Description
Recurrence of atrial fibrillation (AF) will be defined as any ECG documented symptomatic AF, or asymptomatic AF lasting >30 seconds on Mobile Outpatient Cardiac Telemetry (MCOT) monitoring. Subjects will be scheduled for clinic visits at 1, 6, 12 and 24 months post ablation. In addition, mobile outpatient telemetry will be performed for at least seven days at 6, 12 and 24 months post-procedure to detect recurrence of asymptomatic atrial fibrillation.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pulmonary Vein Stenosis
Description
A CT scan of the left atrium and pulmonary veins will be routinely performed 3 months after ablation to assess for any evidence of pulmonary vein stenosis
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with paroxysmal atrial fibrillation, whose episodes have never been documented to exceed 48 hours duration Patients with a clinical indication for ablation Patients greater than 18 years of age. Patients willing and able to give informed consent. Patients with concurrent atrial fibrillation and atrial flutter are allowed. Exclusion Criteria: Patients with medical conditions that would limit participation for the entire duration of the study. Patients that are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment). Patients having undergone prior AF ablation Patients with paroxysmal atrial fibrillation whose episodes last greater than 48 hours Patients with persistent AF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory K Feld, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Sulpizio Cardiovascular Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19410519
Citation
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Shah DC, Haissaguerre M, Jais P, Hocini M, Yamane T, Deisenhofer I, Garrigue S, Clementy J. Electrophysiologically guided ablation of the pulmonary veins for the curative treatment of atrial fibrillation. Ann Med. 2000 Sep;32(6):408-16. doi: 10.3109/07853890008995948.
Results Reference
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PubMed Identifier
11877358
Citation
Oral H, Knight BP, Tada H, Ozaydin M, Chugh A, Hassan S, Scharf C, Lai SW, Greenstein R, Pelosi F Jr, Strickberger SA, Morady F. Pulmonary vein isolation for paroxysmal and persistent atrial fibrillation. Circulation. 2002 Mar 5;105(9):1077-81. doi: 10.1161/hc0902.104712.
Results Reference
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PubMed Identifier
12208802
Citation
Oral H, Knight BP, Ozaydin M, Chugh A, Lai SW, Scharf C, Hassan S, Greenstein R, Han JD, Pelosi F Jr, Strickberger SA, Morady F. Segmental ostial ablation to isolate the pulmonary veins during atrial fibrillation: feasibility and mechanistic insights. Circulation. 2002 Sep 3;106(10):1256-62. doi: 10.1161/01.cir.0000027821.55835.00.
Results Reference
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PubMed Identifier
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Citation
Sawhney N, Anousheh R, Chen WC, Narayan S, Feld GK. Five-year outcomes after segmental pulmonary vein isolation for paroxysmal atrial fibrillation. Am J Cardiol. 2009 Aug 1;104(3):366-72. doi: 10.1016/j.amjcard.2009.03.044. Epub 2009 Jun 6.
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Pappone C, Rosanio S, Oreto G, Tocchi M, Gugliotta F, Vicedomini G, Salvati A, Dicandia C, Mazzone P, Santinelli V, Gulletta S, Chierchia S. Circumferential radiofrequency ablation of pulmonary vein ostia: A new anatomic approach for curing atrial fibrillation. Circulation. 2000 Nov 21;102(21):2619-28. doi: 10.1161/01.cir.102.21.2619.
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Effectiveness Study of Circumferential vs. Segmental Ablation in Paroxysmal Atrial Fibrillation

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