RECABA: Spanish Registry of Cryoballoon Ablation
Study Details
Study Description
Brief Summary
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation.
Secondary objectives are also defined as:
-
Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.).
-
To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
-
Description of the complications related to the procedure.
-
To evaluate the use of healthcare resources which this cryoablation procedure entails.
Study Design
Outcome Measures
Primary Outcome Measures
- The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. [12 months]
Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems).
Secondary Outcome Measures
- The Acute Efficacy of the Procedure: [24-48h]
Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
- Number of Adverse Events Related to the Procedure [Up 30 days post procedure]
The outcome measure is the number of Adverse Events Related to the Procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signature of the Data Release Form
-
Subjects ≥ 18 years old
-
Subjects who meet the indication for the Cryoballoon Ablation procedure.
Exclusion Criteria:
-
Subjects with a life expectancy of less than 12 months.
-
Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.).
-
Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study.
-
Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Trias i Pujol | Badalona | Barcelona | Spain | |
| 2 | H. Josep Trueta | Gerona | Barcelona | Spain | |
| 3 | Hospital Puerta de Hierro | Majadahonda | Madrid | Spain | 28222 |
| 4 | H. Universitario de Canarias | San Cristobal de la Laguna | Santa Cruz De Tenerife | Spain | |
| 5 | Hospital Universitario de Araba | Alava | Spain | ||
| 6 | Hospital Clínico Univeristario San Juan de Alicante | Alicante | Spain | ||
| 7 | Hospital General Universitario de Alicante | Alicante | Spain | ||
| 8 | Hospital del Mar | Barcelona | Spain | ||
| 9 | Clinica Zorrotzaurre | Bilbao | Spain | ||
| 10 | Hospital de Basurto | Bilbao | Spain | ||
| 11 | Hospital Universitario A Coruña | Coruña | Spain | ||
| 12 | Hospital Universitario Reína Sofía | Córdoba | Spain | ||
| 13 | Hospital Universitario Virgen De Las Nieves | Granada | Spain | ||
| 14 | Hospital Juan Ramón Jiménez | Huelva | Spain | ||
| 15 | H. Universitario Insular de las Palmas | Las Palmas de Gran Canaria | Spain | ||
| 16 | Fundación Jiménez Díaz | Madrid | Spain | ||
| 17 | Hospital La Paz | Madrid | Spain | ||
| 18 | Hospital Universitario Rey Juan Carlos | Madrid | Spain | ||
| 19 | Hospital Virgen de la Arrixaca | Murcia | Spain | ||
| 20 | H. C. U. Virgen de la Victoria | Málaga | Spain | ||
| 21 | Hospital Universitario Son Espases | Palma de Mallorca | Spain | ||
| 22 | Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Spain | ||
| 23 | Hospital Nisa-Aljarafe | Sevilla | Spain | ||
| 24 | Hospital Virgen Macarena | Sevilla | Spain | ||
| 25 | H.General de Valencia | Valencia | Spain | ||
| 26 | Hospital Quirón Salud Valencia | Valencia | Spain | ||
| 27 | Hospital Universitario Clínico de Valencia | Valencia | Spain | ||
| 28 | Hospital Universitario y Politécnico de La Fe | Valencia | Spain |
Sponsors and Collaborators
- Medtronic Bakken Research Center
- Medtronic
Investigators
- Principal Investigator: Jesús Daniel Martínez Alday, MD, Hospital de Basurto
- Principal Investigator: Ermengol Vallés, MD, Hospital del Mar
- Principal Investigator: Rocío Cozar, MD, Hospital Virgen del Rocío
- Principal Investigator: Angel Ferrero, MD, Hospital Clínico de Valencia
- Principal Investigator: Arcadio García Alberola, MD, Hospital Virgen de la Arrixaca
Study Documents (Full-Text)
More Information
Publications
None provided.- RECABA
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Patients With Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients With Atrial Fibrillation who meet the indication, according to current clinical practice guidelines, for the Balloon Cryoablation procedure. |
| Period Title: Overall Study | |
| STARTED | 1742 |
| COMPLETED | 1741 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Patients With Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients with paroxysmal and persistent atrial fibrillation who meet criteria to receive a cryoablation procedure. |
| Overall Participants | 1742 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
58
(10)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
543
31.2%
|
| Male |
1199
68.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native | |
| Asian | |
| Native Hawaiian or Other Pacific Islander | |
| Black or African American | |
| White | |
| More than one race | |
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Spain |
1742
100%
|
| Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid (percentage of patients) [Number] | |
| Hypertension |
46.3
|
| Dyslipidemia |
34.7
|
| Diabetes Mellitus |
9.1
|
| Smokers |
13.3
|
| Ischemia Stroke/TIA |
5.3
|
Outcome Measures
| Title | The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. |
|---|---|
| Description | Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems). |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients With Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients with paroxysmal and persistent atrial fibrillation |
| Measure Participants | 1628 |
| Number [percentage of patients freedom from AF] |
79
|
| Title | The Acute Efficacy of the Procedure: |
|---|---|
| Description | Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure. |
| Time Frame | 24-48h |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients With Paroxysmal and Persistent Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients with AF paroxysmal or persistent who meet the criteria for a cryoablation of pulmonary veins. |
| Measure Participants | 1741 |
| Number [participants] |
1726
99.1%
|
| Title | Number of Adverse Events Related to the Procedure |
|---|---|
| Description | The outcome measure is the number of Adverse Events Related to the Procedure |
| Time Frame | Up 30 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Patients With Paroxysmal and Persistent Atrial Fibrillation |
|---|---|
| Arm/Group Description | Patients with AF paroxysmal or persistent who meet the criteria for a cryoablation of pulmonary veins. |
| Measure Participants | 1741 |
| Number [adverse events] |
120
|
Adverse Events
| Time Frame | Adverse events were collected during enrollment and follow up phase, 32 months. | |
|---|---|---|
| Adverse Event Reporting Description | A total of 337 adverse events have been reported, from which 34 were classified as serious. The 337 reported events correspond to 277 different subjects. 83% of reported events are pertaining to one single patient, 13.4% of subjects have more than one adverse event, 3.2% have 3 reported events and one patient (0.4%) had 6 reported adverse events. | |
| Arm/Group Title | Paroxysmal and Persistent Atrial Fibrillation | |
| Arm/Group Description | Patients with paroxysmal or persistent AF who meet the criteria for the crioablation of the pulmonary veins. Events analyzed globally, no per groups. | |
All Cause Mortality |
||
| Paroxysmal and Persistent Atrial Fibrillation | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/1742 (0.3%) | |
Serious Adverse Events |
||
| Paroxysmal and Persistent Atrial Fibrillation | ||
| Affected / at Risk (%) | # Events | |
| Total | 34/1742 (2%) | |
| Cardiac disorders | ||
| Adverse event related to AF not related to procedure | 12/1742 (0.7%) | 12 |
| Infections and infestations | ||
| Unexpected Serious Adverse Device Event | 1/1742 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Adverse event related to procedure | 21/1742 (1.2%) | 21 |
Other (Not Including Serious) Adverse Events |
||
| Paroxysmal and Persistent Atrial Fibrillation | ||
| Affected / at Risk (%) | # Events | |
| Total | 262/1742 (15%) | |
| Cardiac disorders | ||
| Adverse event related to AF not related to procedure | 164/1742 (9.4%) | 201 |
| Unexpected Serious Adverse Device Event | 3/1742 (0.2%) | 3 |
| Injury, poisoning and procedural complications | ||
| Adverse event related to procedure | 95/1742 (5.5%) | 99 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Patricia Pascual |
|---|---|
| Organization | Medtronic Ibérica |
| Phone | 636183869 |
| patricia.pascual@medtronic.com |
- RECABA