Persistent Atrial FibrillationTANTRANCT01672138
Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
A study testing Pulmonary Vein Antrum Isolation, scar homogenization and Non-PV triggers ablation in people with Persistent Atrial Fibrillation and Long-standing Persistent Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
Trial summary
This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Long-standing Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary Vein Antrum Isolation, scar homogenization and Non-PV triggers ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
- Ability to understand and provide signed informed consent
Who cannot join
- Previous 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.
Andrea Natale, MD contact
Mitra Mohanty, MD contact
United States2 sites, 2 recruiting
- Recruiting
St. david's medical Center
Austin, Texas, 78705
Mitra Mohanty, MD, 512-544-8198, mitra1989@gmail.com
mitra1989@gmail.com
- Recruiting
Texas Cardiac arrhythmia Institute, St. David's Hospital
Austin, Texas, 78705
Andrea Natale, MD, 512-544-8186, dr.natale@gmail.com
About this study
Official title: PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers [ PVAI: Pulmonary Vein Antrum Isolation
Non-PV triggers: Triggers arising from sites other than pulmonary veins]
Read the detailed description
Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations.
Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.
- Being tested
- Pulmonary Vein Antrum Isolation, scar homogenization, Non-PV triggers ablation
- Keywords
- PVAI, NPAF, Non-PV triggers
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein Antrum IsolationProcedure or surgery
Also called PVAI
Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
scar homogenizationProcedure or surgery
PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
Non-PV triggers ablationProcedure or surgery
PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall Receives: Procedure: Pulmonary Vein Antrum Isolation |
| Study I | Active comparator | PVAI+ scar homogenization Receives: Procedure: Pulmonary Vein Antrum Isolation; Procedure: scar homogenization |
| Study II | Active comparator | PVAI + isolation of left atrial posterior wall + non-PV triggers ablation Receives: Procedure: Pulmonary Vein Antrum Isolation; Procedure: scar homogenization; Procedure: Non-PV triggers ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia
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.
Measured: 3 years
Secondary outcomes (1)
Improvement in quality of life
Improvement in quality of life
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 posted24 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- RCCS Monzino Hospital, Milan, Italy, Ospedale dell'Angelo, Venezia-Mestre
- 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
- NCT01672138
- Sponsor's protocol ID
- TANTRA_TCAI
- Acronym
- TANTRA
- Status last verified
- Nov 2018
- First submitted
- 21 Aug 2012
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01672138
- Acronym / sponsor ID
- TANTRA / TANTRA_TCAI
- Keywords
- PVAI, NPAF, Non-PV triggers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Collaborators
- RCCS Monzino Hospital, Milan, Italy, Ospedale dell'Angelo, Venezia-Mestre
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Aug 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 study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers [ PVAI: Pulmonary Vein Antrum Isolation
Non-PV triggers: Triggers arising from sites other than pulmonary veins]
Detailed description
Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations.
Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Pulmonary Vein Antrum IsolationPulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall |
| Study I | Active comparator | Procedure: Pulmonary Vein Antrum Isolation, Procedure: scar homogenizationPVAI+ scar homogenization |
| Study II | Active comparator | Procedure: Pulmonary Vein Antrum Isolation, Procedure: scar homogenization, Procedure: Non-PV triggers ablationPVAI + isolation of left atrial posterior wall + non-PV triggers ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
- Ability to understand and provide signed informed consent
Key exclusion criteria (2 listed)
- Previous 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 |
|---|---|---|
| Pulmonary Vein Antrum IsolationAlso: PVAIRadio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall | Procedure or surgery | Control, Study I, Study II |
| scar homogenizationPVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated. | Procedure or surgery | Study I, Study II |
| Non-PV triggers ablationPVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites | Procedure or surgery | Study II |
Primary outcome
Recurrence of atrial arrhythmia
Time frame: 3 years
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 secondary outcome
Improvement in quality of life
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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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 contact
Mitra Mohanty, MD contact
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?
A study testing Pulmonary Vein Antrum Isolation, scar homogenization and Non-PV triggers ablation in people with Persistent Atrial Fibrillation and Long-standing Persistent 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 16 Nov 2018. 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?
Contact Andrea Natale, MD (dr.natale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial arrhythmia (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 16 Nov 2018.