Trial Outcomes & Findings for Spanish Registry of Cryoballoon Ablation (NCT NCT02785991)

NCT ID: NCT02785991

Last Updated: 2025-03-14

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 1742 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-03-14

Participant Flow

Participant milestones

Measure	Patients With Atrial Fibrillation Patients With Atrial Fibrillation who meet the indication, according to current clinical practice guidelines, for the Balloon Cryoablation procedure.
Overall Study STARTED	1742
Overall Study COMPLETED	1741
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race data not collected

Baseline characteristics by cohort

Measure	Patients With Atrial Fibrillation n=1742 Participants Patients with paroxysmal and persistent atrial fibrillation who meet criteria to receive a cryoablation procedure.
Age, Continuous	58 years STANDARD_DEVIATION 10 • n=1742 Participants
Sex: Female, Male Female	543 Participants n=1742 Participants
Sex: Female, Male Male	1199 Participants n=1742 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants Race data not collected
Region of Enrollment Spain	1742 participants n=1742 Participants
Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Hypertension	46.3 percentage of patients n=1742 Participants
Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Dyslipidemia	34.7 percentage of patients n=1742 Participants
Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Diabetes Mellitus	9.1 percentage of patients n=1742 Participants
Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Smokers	13.3 percentage of patients n=1742 Participants
Demographic factors, cardiovascular risk factors (arterial hypertension, diabetes mellitus, dyslipid Ischemia Stroke/TIA	5.3 percentage of patients n=1742 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Patients With Atrial Fibrillation n=1628 Participants Patients with paroxysmal and persistent atrial fibrillation
The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation.	79 percentage of patients freedom from AF

SECONDARY outcome

Timeframe: 24-48h

Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.

Outcome measures

Measure	Patients With Atrial Fibrillation n=1741 Participants Patients with paroxysmal and persistent atrial fibrillation
The Acute Efficacy of the Procedure:	1726 participants

SECONDARY outcome

Timeframe: Up 30 days post procedure

The outcome measure is the number of Adverse Events Related to the Procedure

Outcome measures

Measure	Patients With Atrial Fibrillation n=1741 Participants Patients with paroxysmal and persistent atrial fibrillation
Number of Adverse Events Related to the Procedure	120 adverse events

Adverse Events

Paroxysmal and Persistent Atrial Fibrillation

Serious events: 34 serious events

Other events: 262 other events

Deaths: 5 deaths

Serious adverse events

Measure	Paroxysmal and Persistent Atrial Fibrillation n=1742 participants at risk Patients with paroxysmal or persistent AF who meet the criteria for the crioablation of the pulmonary veins. Events analyzed globally, no per groups.
Injury, poisoning and procedural complications Adverse event related to procedure	1.2% 21/1742 • Number of events 21 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.
Cardiac disorders Adverse event related to AF not related to procedure	0.69% 12/1742 • Number of events 12 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.
Infections and infestations Unexpected Serious Adverse Device Event	0.06% 1/1742 • Number of events 1 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.

Other adverse events

Measure	Paroxysmal and Persistent Atrial Fibrillation n=1742 participants at risk Patients with paroxysmal or persistent AF who meet the criteria for the crioablation of the pulmonary veins. Events analyzed globally, no per groups.
Injury, poisoning and procedural complications Adverse event related to procedure	5.5% 95/1742 • Number of events 99 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.
Cardiac disorders Adverse event related to AF not related to procedure	9.4% 164/1742 • Number of events 201 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.
Cardiac disorders Unexpected Serious Adverse Device Event	0.17% 3/1742 • Number of events 3 • Adverse events were collected during enrollment and follow up phase, 32 months. 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.

Additional Information

Patricia Pascual

Medtronic Ibérica

Phone: 636183869

Email: patricia.pascual@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place