- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881733
Effect of a Bigger Cryoballoon on the Total Antral Lesion Size: Evaluation of POLARx FIT (BETTER-FIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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%).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sing-Chien Yap, MD, PhD
- Phone Number: +31650031551
- Email: s.c.yap@erasmusmc.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015 GD
- Recruiting
- Erasmus Medical Center
-
Contact:
- Sing-Chien Yap, MD, PhD
- Phone Number: +31650031551
- Email: s.c.yap@erasmusmc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- History of symptomatic paroxysmal AF
- Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
- Subjects who are willing and capable of providing informed consent
- Subjects who are willing and capable of participating in all testing associated with this clinical investigation
- Subjects whose age is 18 years or above
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:
- Left ventricular ejection fraction <45% based on most recent transthoracic echocardiogram (TTE) performed <6 months prior to enrollment
- LA diameter >55 mm based on most recent TTE performed <6 months prior to enrollment
- Previous cardiac surgery
- Previous cardiac valvular surgical or percutaneous procedure
- Interatrial baffle, closure device, patch, or occluder
- Unstable angina or ongoing myocardial ischemia
- Moderate or severe valvular heart disease on most recent TTE performed <6 months prior to enrolment
- Congenital heart disease
- Left atrial thrombus
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Patients will undergo cryoablation with the 31 mm balloon size of the POLARx FIT cryoballoon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of antral lesion size after cryoablation with a 31 mm balloon size POLARx FIT
Time Frame: Interprocedural
|
In the pre- and post-ablation UHDx-map, bipolar voltage will be assess using a scar-cutoff <0.3 mV.
The following spatial measurements will be made: (1) the surface areas of the posterior left- and right-sided PV antral isolation, (2) the LAPW surface area with voltage pre- and post-ablation, and (3) the distance between the ipsilateral, antral levels of isolation at superior, middle and inferior latitudes of the LAPW.
The surface area of each PV ostium and the area of the circular antral ablation lesion was measured around each ipsilateral PV pair.
Low-voltage areas will be quantified using a bipolar voltage <0.3 mV.
The scale on the maps will be set from 0.1 to 0.3 mV.
The purple region represents unablated tissue with a bipolar voltage >0.3 mV.
The scar-border zone will be represented by bipolar voltages between 0.1-0.3
mV.
The PV ostium is located by the steep angle between the LA wall and the tubular aspect of the PV.
|
Interprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of grade 4 occlusion with a 31 mm balloon size POLARx FIT (on PV level)
Time Frame: Interprocedural
|
In this study the investigators will evaluate the rate of grade 4 occlusion (i.e., contrast stasis) of the 28 mm and 31 mm balloon size POLARx FIT cryoablation catheter.
Therefore, cine acquisitions of contrast vein occlusions will be analyzed.
Occlusion will be categorized by using a previously described scale (1-rapid outflow of contrast medium from the PV to 4-complete contrast retention with no observable leak).
Two experienced observers blinded to vein outcome will assess recorded venograms.
|
Interprocedural
|
Single shot success rate with a 31 mm balloon size POLARx FIT cryoablation catheter (on PV level).
Time Frame: Interprocedural
|
PV isolation will be determined using conventional criteria: entry- and exit-block as assessed with the circular mapping catheter (POLARMAP).
|
Interprocedural
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sing-Chien Yap, MD, PhD, Erasmus Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC-2023-0325
- NL84423.078.23 (Registry Identifier: CCMO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on POLARx FIT cryoballoon
-
Insel Gruppe AG, University Hospital BernUniversity Hospital, Basel, SwitzerlandActive, not recruitingParoxysmal Atrial FibrillationSwitzerland
-
Staten Island University HospitalUnknownPersistent Atrial FibrillationUnited States
-
Pentax MedicalCompletedEsophageal CancerUnited States
-
Medtronic Cardiac Rhythm and Heart FailureKing's College London; Deutsches Herzzentrum Muenchen; genae associates (CRO)...Completed
-
Shanghai 10th People's HospitalNot yet recruiting
-
G.Gennimatas General HospitalUnknownAtrial Fibrillation | Heart Failure, SystolicGreece
-
Yuksek Ihtisas HospitalCompletedParoxysmal Atrial FibrillationTurkey
-
Pentax MedicalCompletedBarrett's EsophagusUnited States, Netherlands
-
Harald VerheijAcademisch Ziekenhuis Maastricht; Thorax Centrum TwenteCompleted
-
Pentax MedicalCompletedEsophageal CancerNetherlands