Chronic Atrial FibrillationNCT03295422
Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
A study testing RF ablation PVI alone and RF ablation PVI plus LPAW in people with Chronic Atrial Fibrillation and Persistent Atrial Fibrillation, run by Sequoia Hospital at 1 site in United States.
Trial summary
Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- RF ablation PVI alone and RF ablation PVI plus LPAW
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
- Refractory to at least one antiarrhythmic agent.
- Undergoing ablation for the first time.
Who cannot join
- Paroxysmal AF
- Sustained atrial fibrillation lasting more than 3 years
- Left atrial diameter of 60 mm or greater
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dignity Health, Sequoia Hospital
Redwood City, California, 94062
Christopher E Woods, MD, PhD, 650-652-8600, woodsC@sutterhealth.org
Ann Campbell, RN, MBA, 650-367-5950, ann.campbell@dignityhealth.org
About this study
Official title: Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation
Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation
Read the detailed description
Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has emerged as the gold standard for paroxysmal AF with excellent success rates, however, individuals with persistent AF procedural efficacy from pulmonary vein isolation is not optimal. Therefore, improved ablation strategies for these individuals are needed.
This randomized controlled trial will compare two radiofrequency ablation strategies, PVI alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in individuals with persistent AF. Both strategies are currently used to treat persistent AF, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious.
Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for AF. For group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall.
All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for AF, and then two-week ambulatory monitors at 3 months and one year post ablation.
- Being tested
- RF ablation PVI alone, RF ablation PVI plus LPAW
- Keywords
- Persistent Atrial Fibrillation, Radiofrequency ablation, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablation PVI aloneProcedure or surgery
Also called Catheter ablation of the pulmonary veins
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.
RF ablation PVI plus LPAWProcedure or surgery
Also called Catheter ablation of the pulmonary veins plus posterior wall
A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.
| Study group | Role | What they receive |
|---|---|---|
| RF ablation PVI alone | Active comparator | RF catheter ablation of pulmonary veins alone Receives: Procedure: RF ablation PVI alone |
| RF ablation PVI plus LPAW | Experimental | RF catheter ablation PVI plus left atrial posterior wall Receives: Procedure: RF ablation PVI plus LPAW |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year freedom from recurrent atrial arrhythmias
The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start25 Aug 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequoia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher E. Woods, MD, PhD, Sequoia Hospital
- Investigators
- Christopher E Woods, MD, PhD, Principal investigator, Dignity Health, Sequoia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295422
- Sponsor's protocol ID
- Persistent AF Study 01
- Status last verified
- Nov 2020
- First submitted
- 24 Sep 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03295422
- Acronym / sponsor ID
- Persistent AF Study 01
- Keywords
- Persistent Atrial Fibrillation, Radiofrequency ablation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sequoia HospitalUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Sep 2017 (actual)
- 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.
Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation
Detailed description
Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has emerged as the gold standard for paroxysmal AF with excellent success rates, however, individuals with persistent AF procedural efficacy from pulmonary vein isolation is not optimal. Therefore, improved ablation strategies for these individuals are needed.
This randomized controlled trial will compare two radiofrequency ablation strategies, PVI alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in individuals with persistent AF. Both strategies are currently used to treat persistent AF, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious.
Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for AF. For group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall.
All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for AF, and then two-week ambulatory monitors at 3 months and one year post ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF ablation PVI alone | Active comparator | Procedure: RF ablation PVI aloneRF catheter ablation of pulmonary veins alone |
| RF ablation PVI plus LPAW | Experimental | Procedure: RF ablation PVI plus LPAWRF catheter ablation PVI plus left atrial posterior wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
- Refractory to at least one antiarrhythmic agent.
- Undergoing ablation for the first time.
Key exclusion criteria (3 listed)
- Paroxysmal AF
- Sustained atrial fibrillation lasting more than 3 years
- Left atrial diameter of 60 mm or greater
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 |
|---|---|---|
| RF ablation PVI aloneAlso: Catheter ablation of the pulmonary veinsA series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. | Procedure or surgery | RF ablation PVI alone |
| RF ablation PVI plus LPAWAlso: Catheter ablation of the pulmonary veins plus posterior wallA series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines. | Procedure or surgery | RF ablation PVI plus LPAW |
Primary outcome
1-year freedom from recurrent atrial arrhythmias
Time frame: 1 Year
The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Christopher E Woods, MD, PhD principal investigator
Dignity Health, Sequoia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF ablation PVI alone and RF ablation PVI plus LPAW in people with Chronic Atrial Fibrillation and Persistent Atrial Fibrillation, run by Sequoia Hospital at 1 site 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 3 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Christopher E Woods, MD, PhD (650-652-8600, WoodC@sutterhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year freedom from recurrent atrial arrhythmias (time frame: 1 Year). 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 19 Nov 2020.