Paroxysmal Atrial FibrillationABLATENCT01877486
PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by University of Rochester at 1 site in United States.
Trial summary
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- 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: Patients referred for catheter ablation of AF
Who may be able to join
- Aged 18 to 80 years
- Able and willing to give written informed consent
- Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
- Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide
Who cannot join
- Previous ablation for AF
- Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
- Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
- Presence of severe valvular disease with the need for surgical correction
- AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
- Pregnant women or women of child bearing potential and not on reliable methods of birth control
Show all 9Show fewer
- Second or third degree AV block, sinus pause > 3 seconds, resting heart rate< 30 bpm without permanent pacemaker
- History of drug-induced Torsades de Pointes or congenital long QT syndrome
- Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Vein Isolation Using Cryoablation Alone in Paroxysmal Atrial Fibrillation Patients Converted From Persistent Atrial Fibrillation With Dofetilide
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation.
Read the detailed description
Pulmonary vein isolation is now considered a cornerstone of all atrial fibrillation (AF) ablation procedures. In patients with paroxysmal AF, pulmonary vein isolation alone is usually sufficient. The cryoballoon is now FDA approved to achieve PVI in patients with paroxysmal AF.
Although no ablation system is yet approved in patients with persistent AF, these patients are increasingly undergoing ablation. Many investigators feel that these patients have more atrial disease and thus PVI alone is insufficient in these patients. As a result, it is common for these patients to undergo additional ablation, which is often quite extensive and exposes patients to proarrhythmia. Commonly utilized strategies include linear lesions (left atrial roof; mitral isthmus line), ablation of complex fractionated atrial electrograms (CFAEs), left atrial appendage isolation and/or even right atrial ablation. For years, the investigators have been concerned about the adverse effects of this additional ablation. The investigators postulated that the "answer" is not more ablation but trying to "reverse remodel" patients with persistent AF back to a paroxysmal form, whereby PVI alone would again be justified and sufficient. The efficacy of such a strategy has previously been demonstrated.
In brief, the investigators start patients with persistent AF on dofetilide 3 months prior to scheduled ablation. In 96% of patients, AF either suppresses completely or is transformed into a paroxysmal pattern. The net effect is "reverse remodeling" of the left atria. The investigators have confirmed this by using a reduction in P wave duration as a surrogate of remodeling. At the ablation procedure, the investigators perform PVI alone.
- Being tested
- Ablation
- Keywords
- atrial fibrillation, cryoballoon ablation, persistent AF, paroxysmal AF, dofetilide
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Pulmonary vein isolation following dofetilide
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon ablation | After pre-treatment with dofetilide and conversion of persistent AF to sinus rhythm, performance of PVI using cryoballoon Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation/flutter
As assessed by one week Holters and symptoms
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jonathan S. Steinberg, University of Rochester
- Investigators
- Jonathan S Steinberg, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877486
- Sponsor's protocol ID
- UR Cryo PVI
- Acronym
- ABLATE
- Status last verified
- Oct 2016
- First submitted
- 26 May 2013
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation Using Cryoablation Alone in Paroxysmal Atrial Fibrillation Patients Converted From Persistent Atrial Fibrillation With Dofetilide
- ClinicalTrials.gov ID
- NCT01877486
- Acronym / sponsor ID
- ABLATE / UR Cryo PVI
- Keywords
- atrial fibrillation, cryoballoon ablation, persistent AF, paroxysmal AF, dofetilide
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jun 2013 (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.
To determine the efficacy of cryoablation alone in patients with paroxysmal atrial fibrillation who have been pretreated with dofetilide and converted from persistent atrial fibrillation.
Detailed description
Pulmonary vein isolation is now considered a cornerstone of all atrial fibrillation (AF) ablation procedures. In patients with paroxysmal AF, pulmonary vein isolation alone is usually sufficient. The cryoballoon is now FDA approved to achieve PVI in patients with paroxysmal AF.
Although no ablation system is yet approved in patients with persistent AF, these patients are increasingly undergoing ablation. Many investigators feel that these patients have more atrial disease and thus PVI alone is insufficient in these patients. As a result, it is common for these patients to undergo additional ablation, which is often quite extensive and exposes patients to proarrhythmia. Commonly utilized strategies include linear lesions (left atrial roof; mitral isthmus line), ablation of complex fractionated atrial electrograms (CFAEs), left atrial appendage isolation and/or even right atrial ablation. For years, the investigators have been concerned about the adverse effects of this additional ablation. The investigators postulated that the "answer" is not more ablation but trying to "reverse remodel" patients with persistent AF back to a paroxysmal form, whereby PVI alone would again be justified and sufficient. The efficacy of such a strategy has previously been demonstrated.
In brief, the investigators start patients with persistent AF on dofetilide 3 months prior to scheduled ablation. In 96% of patients, AF either suppresses completely or is transformed into a paroxysmal pattern. The net effect is "reverse remodeling" of the left atria. The investigators have confirmed this by using a reduction in P wave duration as a surrogate of remodeling. At the ablation procedure, the investigators perform PVI alone.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon ablation | – | Procedure: AblationAfter pre-treatment with dofetilide and conversion of persistent AF to sinus rhythm, performance of PVI using cryoballoon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for catheter ablation of AF
Key inclusion criteria (4 listed)
- Aged 18 to 80 years
- Able and willing to give written informed consent
- Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
- Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide
Key exclusion criteria (9 listed)
- Previous ablation for AF
- Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
- Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
- Presence of severe valvular disease with the need for surgical correction
- AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
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 |
|---|---|---|
| AblationPulmonary vein isolation following dofetilide | Procedure or surgery | Cryoballoon ablation |
Primary outcome
Freedom from atrial fibrillation/flutter
Time frame: One year
As assessed by one week Holters and symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Paroxysmal Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
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.
Jonathan S Steinberg, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by University of Rochester 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 4 Oct 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Freedom from atrial fibrillation/flutter (time frame: One 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 4 Oct 2016.