Atrial FibrillationPhase 4CORNCT00969735
Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation
A Phase 4 study testing Pulmonary vein cryoablation and Pulmonary vein radiofrequency ablation in people with Atrial Fibrillation, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein cryoablation and Pulmonary vein radiofrequency ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2009to May 2012
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic recurrent paroxysmal AF (>2 episodes in the last 6 months), and
- Refractory to one or more class I or III antiarrhythmic drugs, and
- PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.
Who cannot join
- Age: < 18 or > 75 year-old
- Prior AF ablation
- Pregnancy
- Concomitant acute illness
- Hyperthyroidism
- Moderate to severe valvular heart disease
Show all 11Show fewer
- Prior cardiac surgery
- Left atrium > 50 mm (anteroposterior diameter, parasternal long-axis view)
- Intracardiac thrombus
- Contraindications for anticoagulant therapy
- Inability to be followed in our center for at least 1 year
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Arritmias, Hospital Clínico San Carlos
Madrid, Madrid, 28040
About this study
Official title: Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
Read the detailed description
Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.
An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein cryoablation, Pulmonary vein radiofrequency ablation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoenergy, Implantable loop recorder, Pulmonary vein
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein cryoablationDevice
Also called Cryoenergy balloon catheter ablation
A deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged.
Pulmonary vein radiofrequency ablationDevice
Also called Pulmonary vein isolation
Ablation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter > 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Active comparator | Deflectable over-the-wire cryoablation balloon catheter (Arctic Front®, Cryocath Technologies) Receives: Device: Pulmonary vein cryoablation |
| Radiofrequency ablation | Active comparator | Open irrigation ablation catheter (Navistar® Thermo-cool®, Biosense Webster Inc). Receives: Device: Pulmonary vein radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients without AF recurrences longer than 2 minutes
Measured: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Secondary outcomes (10)
Time to first AF recurrence longer than 2 minutes
Measured: Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period)
Cumulative burden of AF (number of AF episodes longer than 2 minutes)
Measured: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Cumulative burden of AF (percentage of time in AF)
Measured: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.
Measured: Within the first 12 months from ablation
Quality of Life and symptom status
Measured: At the 12th month from ablation
Proportion of patients with procedure-related complications
Measured: Within the first 12 months from ablation
Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)
Measured: At the end of the ablation procedure
Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).
Measured: At the end of the ablation procedure
Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)
Measured: At the end of the ablation procedure
Proportion of pulmonary veins remaining isolated
Measured: At the end of the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Responsible party
- Principal investigator, Nicasio Perez Castellano, Hospital San Carlos, Madrid
- Investigators
- Nicasio Pérez Castellano, MD, PhD, Principal investigator, Unidad de Arritmias, Hospital Clínico San Carlos, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969735
- Sponsor's protocol ID
- COR-1
- Acronym
- COR
- Status last verified
- Apr 2013
- First submitted
- 28 Aug 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoenergy Or Radiofrequency for Pulmonary Vein Isolation (COR Trial)
- ClinicalTrials.gov ID
- NCT00969735
- Acronym / sponsor ID
- COR / COR-1
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoenergy, Implantable loop recorder, Pulmonary vein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Sep 2009 (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 is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter versus the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
Detailed description
Pulmonary vein (PV) isolation using a radiofrequency catheter is the most widespread technique for atrial fibrillation (AF) ablation. These procedures are difficult and time-consuming, because they require precise catheter manipulation and multiple radiofrequency applications. Thus, alternative techniques are being investigated to simplify the procedure. Recently, a cryoenergy balloon catheter has been developed for PV isolation (Arctic Front®, Cryocath Technologies). When this catheter is deployed at the PV antrum, it can create a circumferential lesion around the PV ostium by delivering a single cryoenergy application.
An implantable loop recorder for AF detection has been made available (Reveal XT®, Medtronic). It may help taking clinical decisions regarding anticoagulant and antiarrhythmic therapy and, at the same time, it may be a powerful tool to evaluate the efficacy of different therapeutic strategies.
This is a prospective single-center randomized trial comparing the efficacy and safety of PV cryoablation with the Arctic Front® catheter vs. the standard PV isolation using radiofrequency irrigated tip catheters. The efficacy of both strategies will be evaluated from a clinical point of view and from the detection and quantification of AF episodes by means of the Reveal XT® implantable loop recorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Active comparator | Device: Pulmonary vein cryoablationDeflectable over-the-wire cryoablation balloon catheter (Arctic Front®, Cryocath Technologies) |
| Radiofrequency ablation | Active comparator | Device: Pulmonary vein radiofrequency ablationOpen irrigation ablation catheter (Navistar® Thermo-cool®, Biosense Webster Inc). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic recurrent paroxysmal AF (>2 episodes in the last 6 months), and
- Refractory to one or more class I or III antiarrhythmic drugs, and
- PV anatomy consisting of 4 single PV, with the long diameter of the right superior PV ostium ≤ 20 mm.
Key exclusion criteria (11 listed)
- Age: < 18 or > 75 year-old
- Prior AF ablation
- Pregnancy
- Concomitant acute illness
- Hyperthyroidism
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 |
|---|---|---|
| Pulmonary vein cryoablationAlso: Cryoenergy balloon catheter ablationA deflectable over-the-wire cryoablation balloon catheter (Arctic Front®) will be inflated and be positioned at each PV antrum. Then, cryoenergy will be delivered for 300 seconds. During cryoablation of the right PVs, the right phrenic nerve integrity will be monitored by the observation of right hemi-diaphragm contractions in response to right phrenic nerve pacing at the superior vena cava. Once the 4 PVs are cryoablated, the Arctic Front® catheter will be replaced by a decapolar PV mapping circular catheter (Lasso®, Biosense Webster, Diamond Bar, California, EEUU) to evaluate PV conduction. A second cryoablation application may be delivered at each PV, if necessary. Crossover to RF ablation to complete PV isolation is discouraged. | Device | Cryoablation |
| Pulmonary vein radiofrequency ablationAlso: Pulmonary vein isolationAblation approach is ostial electrical isolation of all PVs with simultaneous use of the CARTO® electroanatomic mapping system (Biosense Webster, Tirat-Ha-Carmel, Israel). PV isolation will be performed by delivering RF energy at ostial sites with earliest PV potentials. Flow rate during the RF applications will be set at 15 mL/min (baseline 2 mL/min). Temperature and power limits will be set at 45ºC and 35 W. It will be allowed a 5 W reduction in power limit setting for small PVs (angiographic supero-inferior diameter > 12 mm), and a 5 W increase in areas located away from the esophagus, and for focal applications at sites resistant to ablation or recurrent gaps. The end-point of ablation will be to achieve bidirectional PV conduction block. | Device | Radiofrequency ablation |
Primary outcome
Proportion of patients without AF recurrences longer than 2 minutes
Time frame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
10 secondary outcomes
Time to first AF recurrence longer than 2 minutes
Time frame: Within the first 12 months from ablation (using a blanking period of 3 months following ablation, and without the use of any blanking period)
Cumulative burden of AF (number of AF episodes longer than 2 minutes)
Time frame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Cumulative burden of AF (percentage of time in AF)
Time frame: At the 12th month from ablation (using a blanking period of 3 months following ablation)
Proportion of patients with episodes of regular atrial tachycardia or atrial flutter requiring treatment with drugs, electrical cardioversion or ablation.
Time frame: Within the first 12 months from ablation
Quality of Life and symptom status
Time frame: At the 12th month from ablation
Proportion of patients with procedure-related complications
Time frame: Within the first 12 months from ablation
Procedure time (minutes elapsed from the first puncture of the femoral vein to the removal of the last catheter)
Time frame: At the end of the ablation procedure
Ablation time (minutes elapsed from the onset of the first energy delivery to the end of the last energy delivery).
Time frame: At the end of the ablation procedure
Fluoroscopy time (minutes of fluoroscopy used during the entire ablation procedure)
Time frame: At the end of the ablation procedure
Proportion of pulmonary veins remaining isolated
Time frame: At the end of the ablation procedure
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 4 Apr 2013.
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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.
Nicasio Pérez Castellano, MD, PhD principal investigator
Unidad de Arritmias, Hospital Clínico San Carlos, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pulmonary vein cryoablation and Pulmonary vein radiofrequency ablation in people with Atrial Fibrillation, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 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 4 Apr 2013. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients without AF recurrences longer than 2 minutes (time frame: At the 12th month from ablation (using a blanking period of 3 months following ablation)). 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 Apr 2013.