Trial Outcomes & Findings for Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT (NCT NCT05881733)

Results Overview

Low-voltage areas will be quantified using a bipolar voltage \<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Interprocedural (directly after cryoablation)

Results posted on

2025-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Study population This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Population n=20 Participants This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Age, Continuous	59.7 years STANDARD_DEVIATION 10.7 • n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	15 Participants n=20 Participants
Region of Enrollment Netherlands	20 participants n=20 Participants

PRIMARY outcome

Timeframe: Interprocedural (directly after cryoablation)

Low-voltage areas will be quantified using a bipolar voltage \<0.3 mV. The sum of the posterior ablated areas of all pulmonary veins is expressed as a percentage of the total left atrial posterior wall.

Outcome measures

Outcome measures
Measure	Study population n=20 Participants This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT	35.4 percentage of posterior wall Standard Deviation 13.8

SECONDARY outcome

Timeframe: Interprocedural (before cryoablation)

Population: There were 4 pulmonary veins per participant. Thus, in 20 participants there were 80 pulmonary veins. We determined the percentage of pulmonary veins which had a grade 4 occlusion with the 31 mm balloon size of the POLARx FIT catheter. In 69 of 80 pulmonary veins (86%) a grade 4 occlusion with the 31 mm balloon size could be achieved.

A grade 4 occlusion is defined as complete contrast stasis. Cine acquisitions of contrast vein occlusions was analyzed by two experienced observers.

Outcome measures

Outcome measures
Measure	Study population n=80 Pulmonary_veins This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT	86 Percentage

SECONDARY outcome

Timeframe: Interprocedural (directly after cryoablation)

Population: There were 4 pulmonary veins per participant. Thus, in 20 participants there were 80 pulmonary veins. We determined the percentage of pulmonary veins which were isolated after 1 cryoapplication with the 31 mm balloon size of the POLARx FIT catheter. 63 of 80 pulmonary veins (79%) were isolated after 1 cryoapplication.

Pulmonary vein isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP).

Outcome measures

Outcome measures
Measure	Study population n=80 Pulmonary_veins This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter	79 Percentage

Adverse Events

Study population

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study population n=20 participants at risk This study will have only a single arm. Patients will undergo pulmonary vein isolation using the 31 mm balloon size of POLARx FIT. High-definition 3D maps will be constructed before and after cryoablation to assess the antral lesion size. POLARx FIT cryoballoon: Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
Gastrointestinal disorders Esophageal perforation	5.0% 1/20 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sing-Chien Yap

Erasmus MC

Phone: +31650031551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place