Atrial FibrillationNCT03115554
Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
A study testing PVI Plus Catheter Ablation and PVI Alone in people with Atrial Fibrillation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI Plus Catheter Ablation and PVI Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 3 Aug 2017
- 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
- (Step 1 - Registration)
- The subject is 18 years of age or older
- Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
- performed within 6 months)
- Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
- Provided written informed consent
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- Be eligible for an AF ablation procedure for Paroxysmal AF
- (Step 2 - Randomization)
- Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation
Who cannot join
- (Step 1 - Registration)
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one-year life expectancy
- Previous cardiac surgery
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices
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- Patients who are contraindicated for anticoagulants such as heparin and warfarin
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous left atrial catheter ablation for AF (does not
- include ablation for AFL or other supraventricular arrhythmias)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- Not competent to legally represent him or herself (e.g., requires a guardian or
- caretaker as a legal representative)
- (Step 2 Randomization)
- Not able to receive additional linear or focal intracardiac catheter ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI Plus Catheter Ablation, PVI Alone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI Plus Catheter AblationProcedure or surgery
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
PVI AloneProcedure or surgery
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
| Study group | Role | What they receive |
|---|---|---|
| PVI Plus Catheter Ablation | Active comparator | Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. Receives: Procedure: PVI Plus Catheter Ablation |
| PVI Alone | Active comparator | Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. Receives: Procedure: PVI Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
Measured: 12 months
Secondary outcomes (1)
Time to recurrence following intervention
Time to recurrence following intervention
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start6 Apr 2017
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
Why it stopped: Patients did not want to be randomized in their procedure.
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasbir Sra, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115554
- Sponsor's protocol ID
- 16-74
- Status last verified
- Dec 2017
- First submitted
- 13 Mar 2017
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03115554
- Acronym / sponsor ID
- 16-74
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients did not want to be randomized in their procedure.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 14 Apr 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.
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI Plus Catheter Ablation | Active comparator | Procedure: PVI Plus Catheter AblationPatients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. |
| PVI Alone | Active comparator | Procedure: PVI AlonePatients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (Step 1 - Registration)
- The subject is 18 years of age or older
- Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
- performed within 6 months)
- Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
Key exclusion criteria (15 listed)
- (Step 1 - Registration)
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one-year life expectancy
- Previous cardiac surgery
- Patients who have active infection or sepsis
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 |
|---|---|---|
| PVI Plus Catheter AblationPatients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. | Procedure or surgery | PVI Plus Catheter Ablation |
| PVI AlonePatients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. | Procedure or surgery | PVI Alone |
Primary outcome
Time to recurrence
Time frame: 12 months
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
1 secondary outcome
Time to recurrence following intervention
Time frame: 12 months post intervention
Results and safety
The study was stopped early (reason given: Patients did not want to be randomized in their procedure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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Atrial Fibrillation (AF)
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.
Jasbir Sra, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI Plus Catheter Ablation and PVI Alone in people with Atrial Fibrillation, run by Wake Forest University Health Sciences 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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?
The study was stopped early (reason given: Patients did not want to be randomized in their procedure.). 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?
Time to recurrence (time frame: 12 months). 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 3 Oct 2024.