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| ID | Type | Description | Link |
|---|---|---|---|
| NL84423.078.23 | Registry Identifier | CCMO |
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The investigators will prospectively evaluate the extent of antral lesion created by the 31 mm balloon size of a novel cryoballoon catheter (POLARx FIT). In 20 patients with paroxysmal atrial fibrillation, the investigators will perform pre- and post-ablation high-definition 3D maps to quantify the extent of lesion created by the 31 mm POLARx FIT cryoballoon.
Rationale: The next generation POLARx cryoablation balloon (CB) catheter will have the option of to deliver cryotherapy with the current balloon size of 28 mm or a new, larger 31 mm size by changing the inner balloon pressure (POLARx FIT, Boston Scientific). Currently, there is no data on the extension of left atrial (LA) lesion formation with the 31 mm balloon size of the POLARx FIT cryoablation balloon catheter. The hypothesis is that a larger CB size results in a wide antral circumferential lesion.
Objective: The primary objective is to evaluate the antral lesion size using ultrahigh-density (UHDx) mapping pre- and post-cryoablation with the 31 mm balloon size CB. Secondary objectives are the proportion of pulmonary veins (PVs) where a 31 mm CB could be positioned to achieve a grade 4 occlusion and the single shot success rate with the 31 mm balloon size CB.
Study design: Single-center, single-arm, prospective study with pre- and post-PVI UHDx mapping.
Study population: Twenty adult patients with paroxysmal AF who are scheduled to undergo pulmonary vein isolation (PVI) with a CB.
Intervention: Patients will undergo pre- and post-ablation UHDx mapping (Orion catheter and Rhythmia 3D-mapping system, Boston Scientific) during the index procedure.
Main study parameters/endpoints: The primary endpoint is the extent of the antral lesion size. Secondary endpoints are the proportion of PVs with grade 4 occlusion with the 31 mm balloon size CB, the single shot success rate of the 31 mm balloon size CB, difference in rate of achieving grade 4 occlusion in comparison to the standard (28 mm) size.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: A UHDx mapping will be acquired before and after complete PVI. The procedures will be performed under deep sedation, which is standard practice for CB procedures in our institution. The risk of additional mapping is limited. LA mapping is a standard diagnostic method for patients undergoing PVI with radiofrequency ("standard-of-care"). In the current study, UHDx mapping will now be used in patients undergoing PVI with CB. The most important complication of additional intracardiac mapping is cardiac tamponade, but this risk is low (<0.5%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POLARx FIT cryoballoon | Device | Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT | 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. | Interprocedural (directly after cryoablation) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT | A grade 4 occlusion is defined as complete contrast stasis. Cine acquisitions of contrast vein occlusions was analyzed by two experienced observers. | Interprocedural (before cryoablation) |
| Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter |
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Inclusion Criteria:
Exclusion Criteria:
Any known contraindication to an AF ablation or anticoagulation
History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
Significant structural heart disease as evidenced by:
History of blood clotting or bleeding disease
Stroke or transient ischemic attack <3 months prior to enrollment
Active systemic infection
Common ostium PV >24 mm defined by CT-scan
Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
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| Name | Affiliation | Role |
|---|---|---|
| Sing-Chien Yap, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | South Holland | 3015 GD | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Ablated Left Atrial Posterior Wall With a 31 mm Balloon Size POLARx FIT | 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. | Posted | Mean | Standard Deviation | percentage of posterior wall | Interprocedural (directly after cryoablation) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophageal perforation | Gastrointestinal disorders | Systematic Assessment | Esophageal perforation requiring major surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sing-Chien Yap | Erasmus MC | +31650031551 | s.c.yap@erasmusmc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2023 | Aug 4, 2025 | Prot_SAP_000.pdf |
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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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Prospective, single-arm, single-center, study
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Pulmonary vein isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP). |
| Interprocedural (directly after cryoablation) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Percentage of Pulmonary Veins With Grade 4 Occlusion With a 31 mm Balloon Size POLARx FIT | A grade 4 occlusion is defined as complete contrast stasis. Cine acquisitions of contrast vein occlusions was analyzed by two experienced observers. | 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. | Posted | Number | Percentage | Interprocedural (before cryoablation) | Pulmonary_veins | Pulmonary_veins |
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|
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| Secondary | Percentage of Pulmonary Veins With a Single Shot Success Rate Using a 31 mm Balloon Size POLARx FIT Cryoablation Catheter | Pulmonary vein isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP). | 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. | Posted | Number | Percentage | Interprocedural (directly after cryoablation) | Pulmonary_veins | Pulmonary_veins |
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| 0 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |