Atrial FlutterNCT01262443
Efficacy of Transcatheter Radiofrequency Ablation of Atrial Flutter With Standard Irrigated Catheter With Flexible Tip
A study testing Radiofrequency Ablation in people with Atrial Flutter, run by Ettore Sansavini Health Science Foundation at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2010to Feb 2014
- 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
- Both sexes; age>18 yrs
- ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
- No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
- Patients willing to accept the tests and to follow standard procedures
- Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment
Who cannot join
- Atrial fibrillation
- Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
- Intra atrial thrombosis
- NYHA class IV
- Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
- Untreated Wolf Parkinson White syndrome
Show all 11Show fewer
- Contraindications to oral anticoagulation
- Life expectancy < 12 month
- Major surgery or interventional procedure already planned in the 6 month following ablation
- Pregnancy or breast-feeding
- Participation in another study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Maria Cecilia Hospital
Cotignola, RA, 48010
Maria Pia Hospital
Torino, TO, 10132
About this study
Official title: Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.
The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.
Read the detailed description
No more available data
- Conditions
- Atrial Flutter
- Being tested
- Radiofrequency Ablation
- Keywords
- Atrial flutter
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationProcedure or surgery
Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
| Study group | Role | What they receive |
|---|---|---|
| Therapy Cool Flex catheter group | Experimental | Therapy Cool Flex Catheter . No more available data Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentual success of the procedure during the hospitalization
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Measured: Up to 4 days
Percentual success of the procedure at 3 months from procedure
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Measured: 3 months
Percentual success of the procedure at 6 months from procedure
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Measured: 6 months
Secondary outcomes (3)
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.
Measured: Up to 4 days; 3-6 month
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given
Measured: Up to 4 days
Safety of the procedure
recording of procedure-related complications
Measured: Up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ettore Sansavini Health Science Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Pappone, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262443
- Sponsor's protocol ID
- ESREFO01
- Status last verified
- May 2014
- First submitted
- 13 Dec 2010
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Acute and 6-month Efficacy of Transcatheter Radiofrequency Ablation of Common Atrial Flutter With a Standard Irrigated Catheter With Flexible Tip.
- ClinicalTrials.gov ID
- NCT01262443
- Acronym / sponsor ID
- ESREFO01
- Conditions
- Atrial Flutter
- Keywords
- Atrial flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ettore Sansavini Health Science FoundationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Dec 2010 (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.
The purpose of this study is to evaluate the efficacy of transcatheter ablation of atrial flutter with a standard irrigated catheter with flexible tip, as evaluated by percentual success of the procedure.
Detailed description
No more available data
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy Cool Flex catheter group | Experimental | Procedure: Radiofrequency AblationTherapy Cool Flex Catheter . No more available data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes; age>18 yrs
- ECG documentation of at least 2 episodes of common atrial flutter or evidence of ongoing atrial flutter.
- No contraindications to transcatheter radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
- Patients willing to accept the tests and to follow standard procedures
- Patients who understand the nature of the procedure and who are willing to participate and to sign the informed consent before enrollment
Key exclusion criteria (11 listed)
- Atrial fibrillation
- Any arrhythmia requiring antiarrhythmics in the 6 months post procedure
- Intra atrial thrombosis
- NYHA class IV
- Unstable Angina or Acute Myocardial Infarction (AMI) in the last 3 month
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 |
|---|---|---|
| Radiofrequency AblationRadiofrequency ablation by a standard 4mm irrigated flexible tip catheter | Procedure or surgery | Therapy Cool Flex catheter group |
Primary outcome
Percentual success of the procedure during the hospitalization
Time frame: Up to 4 days
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 3 months from procedure
Time frame: 3 months
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
Percentual success of the procedure at 6 months from procedure
Time frame: 6 months
Procedural success is defined as evidence of bidirectional block of cava tricuspidal istmus. The presence of block will be evaluated by mapping the electrical activation of the right atrium before and after pacing from thecoronary synus.
3 secondary outcomes
•Synus rhythm maintenance in the absence of antiarrhythmics within 6 month from procedure.
Time frame: Up to 4 days; 3-6 month
Duration of ablation procedure, number of radiofrequency erogations, duration and total energy given
Time frame: Up to 4 days
Safety of the procedure
Time frame: Up to 4 days
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 3 Oct 2016.
- 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.
Carlo Pappone, MD principal investigator
Maria Cecilia Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Atrial Flutter, run by Ettore Sansavini Health Science Foundation at 2 sites in Italy.
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 5 inclusion and 11 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 3 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 2 sites in Italy. 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 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?
Percentual success of the procedure during the hospitalization (time frame: Up to 4 days). The study lists 3 primary outcomes in all. 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 2016.