Trial Outcomes & Findings for PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF) (NCT NCT00774566)

NCT ID: NCT00774566

Last Updated: 2021-04-06

Results Overview

Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 322 participants
• Primary outcome timeframe: Six months after procedure
• Results posted on: 2021-04-06

Participant Flow

A total of 322 patients were included, with 7 not receiving treatment as part of the trial because of a withdrawal of consent but without knowing group assignment leaving 315 patients randomly assigned. This resulted in a final ITT population of 315 patients.

Participant milestones

Measure	Radiofrequency (RF) Ablation Patients in this arm were treated with the established RF ablation approach with an open irrigated tip ablation catheter for the treatment of paroxysmal atrial fibrillation. All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.	Cryo Balloon(CB) Ablation Patients in this arm were treated with the cryo balloon ablation technique for the tretment of paoxysmal atrial fibrillation (AF). All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.
Overall Study STARTED	159	156
Overall Study 6 Month Follow up	154	150
Overall Study 12 Month Follow up	141	141
Overall Study COMPLETED	141	141
Overall Study NOT COMPLETED	18	15

Reasons for withdrawal

Measure	Radiofrequency (RF) Ablation Patients in this arm were treated with the established RF ablation approach with an open irrigated tip ablation catheter for the treatment of paroxysmal atrial fibrillation. All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.	Cryo Balloon(CB) Ablation Patients in this arm were treated with the cryo balloon ablation technique for the tretment of paoxysmal atrial fibrillation (AF). All patients have at least experienced 2 episodes of AF within the last 3 month before inclusion.
Overall Study Protocol Violation	18	15

Baseline Characteristics

PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)

Baseline characteristics by cohort

Measure	RF Ablation n=159 Participants Patients that have been randomized into the RF ablation group and have recieved the treatment as per protocol	CB Ablation n=156 Participants Patients that have been randomized into the cryo balloon ablation group and have recieved the treatment as per protocol	Total n=315 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	56 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	100 Participants n=7 Participants	191 Participants n=5 Participants
Diabetes mellitus	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Hypertension	103 Participants n=5 Participants	96 Participants n=7 Participants	199 Participants n=5 Participants
Stroke	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six months after procedure

Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.

Outcome measures

Measure	RF Ablation n=154 Participants patients that have undergone RF ablation	CB Ablation n=150 Participants patients that have undergone CB ablation
Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications at Six Months After the Index Procedure	99 Participants	98 Participants

PRIMARY outcome

Timeframe: Twelve month after the procedure

Including redo procedures. Redo procedures were only allowed after the 6 month follow up. Redo procedures had to be performed using the same energy source. No ADD administration was allowed after the ablation procedure.

Outcome measures

Measure	RF Ablation n=141 Participants patients that have undergone RF ablation	CB Ablation n=141 Participants patients that have undergone CB ablation
Combined Endpoint Out of: Absence of Atrial Arrhythmias and Absence of Persistent Complications Twelve Months After Procedure.	103 Participants	105 Participants

SECONDARY outcome

Timeframe: Twelve month after the procedure

Population: patients that meet all protocol criteria (PP) after 12 month follow up

Absence of atrial arrhythmias at twelve months after procedure.

Outcome measures

Measure	RF Ablation n=159 Participants patients that have undergone RF ablation	CB Ablation n=156 Participants patients that have undergone CB ablation
Long-term Clinical Success	141 Participants	141 Participants

SECONDARY outcome

Timeframe: at time of the procedure

Population: all patients the have been treated per protocol (PP)

Analyzes the differences in x-ray dosage exposure during the procedures

Outcome measures

Measure	RF Ablation n=159 Participants patients that have undergone RF ablation	CB Ablation n=156 Participants patients that have undergone CB ablation
Total Radiation Exposure	50.0 cGy Interval 24.0 to 79.0	61.5 cGy Interval 36.0 to 97.0

SECONDARY outcome

Timeframe: at time of the procedure

Population: all patients that have been treated per protocol (PP)

Analyzes the differences in procedure duration

Outcome measures

Measure	RF Ablation n=159 Participants patients that have undergone RF ablation	CB Ablation n=156 Participants patients that have undergone CB ablation
Total Procedure Duration	162.0 min Interval 133.0 to 200.0	151.0 min Interval 119.0 to 182.0

SECONDARY outcome

Timeframe: procedure date till 12 month after the procedure

Population: all patients that have been treated per protocol (PP)

calculated as freedom from any major adverse events until 12 month follow up period

Outcome measures

Measure	RF Ablation n=159 Participants patients that have undergone RF ablation	CB Ablation n=156 Participants patients that have undergone CB ablation
Major Adverse Events patietns without any event	147 Participants	144 Participants
Major Adverse Events patients with missing information	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Six month after the procedure

Population: patients that meet all protocol criteria (PP) after 6 month follow up

Absence of atrial arrhythmias at six months after procedure.

Outcome measures

Measure	RF Ablation n=159 Participants patients that have undergone RF ablation	CB Ablation n=156 Participants patients that have undergone CB ablation
Mid-term Clinical Success	154 Participants	150 Participants

Adverse Events

RF Ablation

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

CB Ablation

Serious events: 9 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	RF Ablation n=159 participants at risk all patients that underwent RF ablation procedure	CB Ablation n=156 participants at risk all patients that underwent CB ablation procedure
Vascular disorders Vascular complication	2.5% 4/159 • Number of events 4 • at procedure, 6 and 12 month after procedure	3.2% 5/156 • Number of events 5 • at procedure, 6 and 12 month after procedure
Respiratory, thoracic and mediastinal disorders Phrenic nerve palsy	0.00% 0/159 • at procedure, 6 and 12 month after procedure	1.3% 2/156 • Number of events 2 • at procedure, 6 and 12 month after procedure
Cardiac disorders Pericardial effusion	0.00% 0/159 • at procedure, 6 and 12 month after procedure	1.3% 2/156 • Number of events 2 • at procedure, 6 and 12 month after procedure

Other adverse events

Measure	RF Ablation n=159 participants at risk all patients that underwent RF ablation procedure	CB Ablation n=156 participants at risk all patients that underwent CB ablation procedure
Vascular disorders Valscular complication	0.63% 1/159 • Number of events 1 • at procedure, 6 and 12 month after procedure	1.3% 2/156 • Number of events 2 • at procedure, 6 and 12 month after procedure
Respiratory, thoracic and mediastinal disorders Phrenic nerve palsy	0.00% 0/159 • at procedure, 6 and 12 month after procedure	3.8% 6/156 • Number of events 6 • at procedure, 6 and 12 month after procedure
Cardiac disorders Pericardial effusion	1.3% 2/159 • Number of events 2 • at procedure, 6 and 12 month after procedure	0.00% 0/156 • at procedure, 6 and 12 month after procedure

Additional Information

Dr. Armin Luik

Stardtisches Klinikum Karlsruhe, Medizinische Klinik IV

Phone: 0049-721974

Email: armin.luik@klinikum-karlsruhe.de

Results disclosure agreements

• Principal investigator is a sponsor employee This is an investigator initiated study. The study was supported with 20.000 EUR to acquire Holter monitor devices by CryoCath/Medtronic.
• Publication restrictions are in place

Restriction type: OTHER