Atrial FibrillationPhase 3NCT02325778
Comparison of CTI Ablation Prior to or After LA Ablation for AF
A Phase 3 study testing CTI ablation Timing in people with Atrial Fibrillation, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after… 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?
- CTI ablation Timing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2016
- Phase
- Phase 3
- 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
- continuous/persistent atrial fibrillation
Who cannot join
- age<18
- congenital heart disease
- pacemaker or ICD implant
- previous ablation
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Randomized, Single-blind, Comparative Trial of Two AF Ablation Strategies (CTI Ablation Prior to LA Ablation Versus CTI After LA Ablation) to Eliminate Persistent AF
This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.
- Conditions
- Atrial Fibrillation
- Being tested
- CTI ablation Timing
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTI ablation TimingProcedure or surgery
The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.
| Study group | Role | What they receive |
|---|---|---|
| CTI First | Experimental | CTI ablation prior to left atrial ablation Receives: Procedure: CTI ablation Timing |
| CTI second | Experimental | CTI ablation after left atrial ablation Receives: Procedure: CTI ablation Timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
Measured: Acute (intra procedure)
Secondary outcomes (1)
Early recurrence of atrial arrhythmias
Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJan 2010
- Primary completionJul 2016
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 NYU Langone HealthThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Aizer, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325778
- Sponsor's protocol ID
- 10-01007
- Status last verified
- Aug 2016
- First submitted
- 16 Dec 2014
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Comparative Trial of Two AF Ablation Strategies (CTI Ablation Prior to LA Ablation Versus CTI After LA Ablation) to Eliminate Persistent AF
- ClinicalTrials.gov ID
- NCT02325778
- Acronym / sponsor ID
- 10-01007
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2016 (actual)
- First posted
- 25 Dec 2014 (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 is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTI First | Experimental | Procedure: CTI ablation TimingCTI ablation prior to left atrial ablation |
| CTI second | Experimental | Procedure: CTI ablation TimingCTI ablation after left atrial ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- continuous/persistent atrial fibrillation
Key exclusion criteria (4 listed)
- age<18
- congenital heart disease
- pacemaker or ICD implant
- previous ablation
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 |
|---|---|---|
| CTI ablation TimingThe timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure. | Procedure or surgery | CTI First, CTI second |
Primary outcome
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
Time frame: Acute (intra procedure)
1 secondary outcome
Early recurrence of atrial arrhythmias
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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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.
Anthony Aizer, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CTI ablation Timing in people with Atrial Fibrillation, run by NYU Langone Health 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Aug 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm (time frame: Acute (intra procedure)). 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 8 Aug 2016.