Atrial FibrillationCRYO-LATSNCT03199703
Conventional Versus RF Needle Transseptal Puncture for Cryoballoon Ablation
A study testing Baylis transseptal system group and Standard conventional transseptal group in people with Atrial Fibrillation, run by Jason Andrade at 6 sites in Canada.
Trial summary
This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Baylis transseptal system group and Standard conventional transseptal group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 6 sitesCanada
- Study dates
- 17 Jan 2017to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- Age of 18 years or older on the date of consent
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Who cannot join
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
Show all 22Show fewer
- Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- Cardiac valve prosthesis
- Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
- Cardiac surgery during the three-month interval preceding the consent date
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) less than 35%
- Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- Significant Chronic Kidney Disease (CKD - eGFR <30 µMol/L)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- Pregnancy
- Life expectancy less than one (1) year
- Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- Unwilling or unable to comply fully with study procedures and follow-up
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Queen Elizabeth II
Halifax, Nova Scotia
Southlake Regional Health Centre
Newmarket, Ontario
Université Laval
Québec, Quebec
University of Saskatchewan
Saskatoon, Saskatchewan
St. Paul's Hospital
Vancouver, British Columbia
Vancouver General Hospital, University of British Columbia
Vancouver, British Columbia
About this study
Official title: Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Read the detailed description
Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures.
Trial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
- Conditions
- Atrial Fibrillation
- Being tested
- Baylis transseptal system group, Standard conventional transseptal group
- Keywords
- PVI Ablation, Cryoballoon
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baylis transseptal system groupDevice
Standard conventional transseptal groupDevice
| Study group | Role | What they receive |
|---|---|---|
| Baylis transseptal system group | Active comparator | Patients randomized to the Baylis transseptal system group (Bayliss Group) will undergo transseptal puncture with a large, preformed curve 71-cm-C1 or 98-cm-C1 18-gauge NRG needle (Baylis Medical) through a TorFlex sheath (Baylis Medical), with the sheath curve selected at the discretion of the operating physician. Receives: Device: Baylis transseptal system group |
| Conventional transseptal group | Active comparator | Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with either a large, preformed curve 71- or 98-cm 18-gauge BRK needle (BRK, BRK-1, BRK-2 needle, St. Jude Medical) through any non-Baylis sheath (for example Schwartz SL, Biosense-Webster Preface) selected at the discretion of the operating physician. Receives: Device: Standard conventional transseptal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time required for left atrial access
defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium.
Measured: Intraprocedural assessment (within 24 hours)
Secondary outcomes (5)
Transeptal Access
Success/failure of the assigned transseptal apparatus to achieve transeptal puncture (proportion of patients necessitating the use of the alternate study apparatus - e.g. cross-over from the NRG RF needle to the to conventional BRK needle)
Measured: Intraprocedural assessment (within 24 hours)
Plastic Shavings
Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen
Measured: Intraprocedural assessment of visible plastic shavings (within 24 hours)
The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture
Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture
Measured: Acute peri-procedural complications will be defined as occurring within 30 days of ablation
Transseptal time - septal engagement to sheath advancement
Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA
Measured: Intraprocedural assessment (measured in seconds)
Transseptal time - left atrial access to sheath positioning
Time from needle advancement through the septum to sheath advancement into the LA
Measured: Intraprocedural assessment (measured in seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start17 Jan 2017
- Primary completion17 May 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Andrade
- Sponsor type
- University, hospital or other
- Collaborators
- Baylis Medical Company
- Responsible party
- Sponsor-investigator, Jason Andrade, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199703
- Sponsor's protocol ID
- 6-May-16
- Acronym
- CRYO-LATS
- Status last verified
- Dec 2020
- First submitted
- 9 Jun 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andrade JG, Macle L, Bennett MT, Hawkins NM, Essebag V, Champagne J, Roux JF, Makanjee B, Tang A, Skanes A, Khaykin Y, Morillo C, Jolly U, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Wells GA, Verma A, Deyell MW. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022 Nov;65(2):481-489. doi: 10.1007/s10840-022-01277-y. Epub 2022 Jun 24.
PubMed 35739438
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
- ClinicalTrials.gov ID
- NCT03199703
- Acronym / sponsor ID
- CRYO-LATS / 6-May-16
- Conditions
- Atrial Fibrillation
- Keywords
- PVI Ablation, Cryoballoon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Jason AndradeUniversity, hospital or other
- Collaborators
- Baylis Medical Company
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Detailed description
Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures.
Trial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
| Arm | Type | Receives |
|---|---|---|
| Baylis transseptal system group | Active comparator | Device: Baylis transseptal system groupPatients randomized to the Baylis transseptal system group (Bayliss Group) will undergo transseptal puncture with a large, preformed curve 71-cm-C1 or 98-cm-C1 18-gauge NRG needle (Baylis Medical) through a TorFlex sheath (Baylis Medical), with the sheath curve selected at the discretion of the operating physician. |
| Conventional transseptal group | Active comparator | Device: Standard conventional transseptal groupPatients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with either a large, preformed curve 71- or 98-cm 18-gauge BRK needle (BRK, BRK-1, BRK-2 needle, St. Jude Medical) through any non-Baylis sheath (for example Schwartz SL, Biosense-Webster Preface) selected at the discretion of the operating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- Age of 18 years or older on the date of consent
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Key exclusion criteria (22 listed)
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baylis transseptal system group | Device | Baylis transseptal system group |
| Standard conventional transseptal group | Device | Conventional transseptal group |
Primary outcome
Total time required for left atrial access
Time frame: Intraprocedural assessment (within 24 hours)
defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium.
5 secondary outcomes
Transeptal Access
Time frame: Intraprocedural assessment (within 24 hours)
Plastic Shavings
Time frame: Intraprocedural assessment of visible plastic shavings (within 24 hours)
The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture
Time frame: Acute peri-procedural complications will be defined as occurring within 30 days of ablation
Transseptal time - septal engagement to sheath advancement
Time frame: Intraprocedural assessment (measured in seconds)
Transseptal time - left atrial access to sheath positioning
Time frame: Intraprocedural assessment (measured in seconds)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Derived from this study: PubMed 35739438Andrade JG, Macle L, Bennett MT, Hawkins NM, Essebag V, Champagne J, Roux JF, Makanjee B, Tang A, Skanes A, Khaykin Y, Morillo C, Jolly U, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Wells GA, Verma A, Deyell MW. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022 Nov;65(2):481-489. doi: 10.1007/s10840-022-01277-y. Epub 2022 Jun 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baylis transseptal system group and Standard conventional transseptal group in people with Atrial Fibrillation, run by Jason Andrade at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time required for left atrial access (time frame: Intraprocedural assessment (within 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.