Atrial FibrillationTARGETNCT01696344
Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome?
An observational study of Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
Trial summary
This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVAI and PVAI + ablation of extraPV triggers
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Drug-refractory long-standing persistent atrial fibrillation
Who may be able to join
- Age ≥ 18 years
- LSP-AF patients experiencing AF termination during ablation
- Ability to understand and provide signed informed consent
Who cannot join
- Previous left atrial catheter ablation or MAZE procedure in left atrium
- Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. david's Medical Center
Austin, Texas, 78705
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, 78705
About this study
Official title: Does AF Termination Without Additional Ablation Influence Outcome?
This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.
Read the detailed description
Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.
Hypothesis: AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.
- Conditions
- Atrial Fibrillation
- Being tested
- PVAI, PVAI + ablation of extraPV triggers
- Keywords
- LSPAF, AF termination, PVAI, nonPV triggers, Long-standing persistent
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVAIProcedure or surgery
Also called Pulmonary vein antrum isolation
PVAI + ablation of extraPV triggersProcedure or surgery
PVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | No additional ablation after AF termination(PVAI only) Receives: Procedure: PVAI | |
| Cohort 2 | Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers) Receives: Procedure: PVAI + ablation of extraPV triggers |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
Any episode of AF/AT 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2018
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- California Pacific Medical Center
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, TCAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696344
- Sponsor's protocol ID
- TCAI_TARGET
- Acronym
- TARGET
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2012
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does AF Termination Without Additional Ablation Influence Outcome?
- ClinicalTrials.gov ID
- NCT01696344
- Acronym / sponsor ID
- TARGET / TCAI_TARGET
- Conditions
- Atrial Fibrillation
- Keywords
- LSPAF, AF termination, PVAI, nonPV triggers, Long-standing persistent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Collaborators
- California Pacific Medical Center
- Study start
- May 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims to investigate if termination of atrial fibrillation (AF) after pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in long-standing persistent (LSP) AF, is enough to ensure long-term success.
Detailed description
Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences suggest that when high frequency of atrial activation is maintained for relatively longer period (as in persistent or long-standing AF), ion channel remodeling changes the electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as anticipated, demonstrates to have limited success rate in persistent and LSP AF and additional ablations beyond PVAI involving substrate modification are advocated by many experts in electrophysiology. However, there is yet no consensus on the ablation strategy for long-standing AF. It is still not clear whether AF termination during ablation could be considered as an ablation endpoint or not, as earlier studies have reported results that are at variance with each other. Some studies have suggested that termination of AF during ablation is associated with reduced recurrence of arrhythmia while others detected no association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF termination with or without additional ablation of extra-PV triggers.
Hypothesis: AF termination does not eliminate the need for additional ablations in achieving long-term ablation success in LSP-AF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Procedure: PVAINo additional ablation after AF termination(PVAI only) |
| Cohort 2 | – | Procedure: PVAI + ablation of extraPV triggersAdditional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Drug-refractory long-standing persistent atrial fibrillation
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- LSP-AF patients experiencing AF termination during ablation
- Ability to understand and provide signed informed consent
Key exclusion criteria (2 listed)
- Previous left atrial catheter ablation or MAZE procedure in left atrium
- Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVAIAlso: Pulmonary vein antrum isolation | Procedure or surgery | Cohort 1 |
| PVAI + ablation of extraPV triggersPVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage | Procedure or surgery | Cohort 2 |
Primary outcome
AF recurrence
Time frame: 3 years
Any episode of AF/AT 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
TCAI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.