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| Name | Class |
|---|---|
| Centro Cardiologico Monzino | OTHER |
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A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation.
The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon ablation | Active Comparator | Cryoballoon pulmonary vein isolation with the Arctic Front AdvanceĀ® System or any future development generations of this product line. |
|
| Radiofrequency Ablation | Active Comparator | Contact force-sensing radiofrequency left atrial ablation with 3D mapping system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Procedure | Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial tachycardia/fibrillation | Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of AF episodes recorded. | 12 months | |
| Duration of AF episodes recorded. | 12 months | |
| Length of postoperative hospital stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni B Forleo, MD, PhD | Contact | +390239042789 | gbforleo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Claudio Tondo, MD, PhD | Heart Rhythm Center at Monzino Cardiac Center, IRCCS. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera - Polo Universitario - "Luigi Sacco" | Recruiting | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27381589 | Result | Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5. | |
| 27042964 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| Cryoballoon ablation | Procedure | Cryoballoon pulmonary vein isolation with the Arctic Front AdvanceĀ® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure. |
|
|
| 1 month |
| Total procedural time. | 1 day |
| Fluoroscopy time | 1 day |
| Left atrial instrumentation time | total time during which there are catheters in the LA | 1 day |
| Hospitalizations after discharge. | number of hospitalizations after discharge | 12 months |
| Procedure-related complications | Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal. | 1 week |
| Incidence of cerebrovascular events from the time of the operation up to 90 days. | 90 Days |
| Long-term success | freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy. | 36 months |
| Freedom from clinical or stroke-relevant AF/AFL/AT. | Freedom from AF/AFL/AT with duration cutoff > 1 hour | 12 months |
| Freedom from persistent AF/AFL/AT (duration cutoff of 7 days) | Freedom from AF/AFL/AT with duration cutoff > 7 days | 12 months |
| Regression from persistent to non-paroxysmal atrial fibrillation | Patients converted into paroxysmal forms of AF. | 12 months |
| Significant reduction in AF burden | >75% reduction from pre- to postablation and/or total postablation burden <12% | 12 months |
| Low daily AF burden | Patients with AF burden less than 1%- 2% | 12 months |
| Death from any cause | 12 months |
| Heart Rhythm Center at Monzino Cardiac Center, IRCCS. | Not yet recruiting | Milan | Italy |
|
| Istituto Clinico S. Ambrogio | Not yet recruiting | Milan | Italy |
|
| Result |
| Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |