Atrial FibrillationCAPCOSTNCT01562912
Efficiency Study Evaluating the Use of PVAC Catheter Technology for Performing Ablation in Pts With Atrial Fibrillation
A study testing Radiofrequency Ablation Procedure and PVAC Ablation Procedure in people with Atrial Fibrillation, run by Newmarket Electrophysiology Research Group Inc at 6 sites in Canada.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating symptoms, adversely affect patient's (pt's) quality of life and functional status. 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?
- Radiofrequency Ablation Procedure and PVAC Ablation Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 6 sitesCanada
- Study dates
- Feb 2012to Mar 2018
- 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
- Patients aged 18 years or greater.
- Patients undergoing first-time catheter ablation for AF.
- Patients with paroxysmal AF. Paroxysmal AF will be defined as self-terminating episodes less than 7 days duration. Patients should have had at least 3 episodes of AF in a one year period.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of enrollment in the study.
- Patients must be able and willing to provide written informed consent to participate in the clinical study.
Who cannot join
- Patients with persistent AF (defined as an episode of AF lasting >7 days).
- Patients with AF felt to be secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor.
- Patients who have previously undergone AF ablation.
- Patients with left atrial size >/= 55 mm (2D echocardiography, parasternal long axis view).
- Patients who are or may potentially be pregnant.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Hamilton Health Sciences
Hamilton, Ontario
London Health Sciences Center
London, Ontario, N6A 5A5
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: The Prospective, Multicenter Canadian Atrial Fibrillation PVAC Cohort Study
Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating symptoms, adversely affect patient's (pt's) quality of life and functional status. Hence a strategy of sinus rhythm (SR) may be pursued over a strategy of allowing AF to persist. Percutaneous catheter ablation is an effective alternative to antiarrhythmic drugs (AAD) for maintaining SR. The success rate of PV isolation off AAD is about 80-90% in pt's with PAF, but repeat procedures are required in up to 40% of pt's. After one ablation, the success rate may only be 50-70% off drugs.Current standard ablation procedures for PV antral isolation employ mapping systems which reconstructions of the LA and PV anatomy are created. Visualization may be supplemented by integration of CT/ MRI images and/or intracardiac echocardiography. Robotic navigation has been employed to assist in ablation. Based on single point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point around the PVs to obtain electrical isolation.This results in lengthy complex, costly procedures,often more than 4 hours, which requires high degree of operator skill.Creation of contiguous, transmural lesions is challenging with standard single-point RF. A novel multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC catheter, Medtronic Inc.) An over-the-wire circular mapping/ablation catheter can be advanced into the PV antrum, and multiple lesions around the circumference of the catheter can be delivered simultaneously using duty-cycled unipolar and bipolar RF energy. Early reports, the system can achieve complete PV isolation with reduced fluoroscopy and procedural times using lower powers to achieve more reliable lesion sets.Long-term efficacy also seems comparable to standard RF ablation.This novel technology has potential to broaden the application of AF ablation, making procedures less time-consuming, less complex without compromising procedural efficacy. Published data PVAC technology outcomes are limited to studies with small sample sizes of 12-102 pt's. Data has been restricted to a small number of European centers performing moderate numbers of PVAC procedures. There is no prospective, multicenter data. Little is known about the efficiency of PVAC procedures, allowing for an assessment of cost-effectiveness in using this technology.
Read the detailed description
This is a multicenter, open label, prospective, cohort study. Patients undergoing ablation with PVAC technology in up to 15 centers across Canada will be enrolled, ablated, and followed for one year post-ablation. Both primary and secondary objectives of the study will be determined from this cohort of patients. Comparisons to the traditional ablation methods will be made by collecting data from a prospective group of control subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. While the final ratio of control to PVAC patients must be 1:2 by study end for each operator, the ratio may vary while the study is conducted to allow some flexibility in patient recruitment. However, the absolute difference between [# of PVAC patients] and 2x[# control patients] should not exceed 5 at any given time for any operator in any study center
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency Ablation Procedure, PVAC Ablation Procedure
- Keywords
- radiofrequency, ablation, atrial fibrillation, PVAC
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation ProcedureDevice
Also called THERMOCOOL Catheter, Biosense Webster, EnSite NavX Velocity, St Jude, LASSO Circular Mapping Catheter, Biosense Webster
Application of radiofrequency energy will be delivered during PV antral isolation procedure and should be performed with a standard, open irrigated ablation catheter and a mapping system as the investigator would perform the procedure normally.
PVAC Ablation ProcedureDevice
Also called PVAC Catheter, Medtronic Inc., Ablation Frontiers
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter(PVAC)to eliminate potentials arising from the pulmonary veins.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Radiofrequency Ablation Procedure. Subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. Intervention is the use of Radiofrequency Ablation. Receives: Device: Radiofrequency Ablation Procedure |
| PVAC Ablation Procedure | Experimental | Intervention is the use of PVAC technology. The PVAC is deployed in the left atrium over a 0.032-inch guidewire inside the PV and advanced until it is wedged within the antrum proximal to the ostium. Energy is delivered through selected electrode pairs with local potentials as well as adjacent electrode pairs, allowing bipolar current to flow to the target electrode(s) from both sides. Each application lasts for 60 seconds. When the temperature does not rise above 50°C within 15 seconds, the application should be discontinued to improve position. The PVAC may be manipulated within the antrum to ablate in a pattern of overlapping circular lesions. Receives: Device: PVAC Ablation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Duration and Fluoroscopy time
Length of procedure measure in hours/minutes and use of fluoroscopy measured in minutes
Measured: At the time of the initial ablation procedure and repeat ablations.
Secondary outcomes (3)
Incidence of emergency room visits, hospitalizations and urgent clinic visits.
Incidence of emergency room visits, hospitalizations and urgent clinic visits one year prior to ablation and 3, 6, 9, and 12 months post ablation.
Measured: 1 year follow-up post ablation
Quality of Life measurements (CCS-SAF, AFEQT and SF-12)
Quality of Life measurements (CCS-SAF , AFEQT and SF-12) questionnaires at baseline, 3, 6 , 9 and 12 months.
Measured: 1 year post ablation
Total ablation procedure costs.
calculation of procedural costs
Measured: 1 year post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2017
- Study completionMar 2018
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newmarket Electrophysiology Research Group Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Atul Verma, MD, Principal investigator, Newmarket Electrophysiology Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562912
- Sponsor's protocol ID
- NERG-01
- Acronym
- CAPCOST
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2012
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: to be determined
Publications
Essebag V, Azizi Z, Alipour P, Khaykin Y, Leong-Sit P, Sarrazin JF, Sturmer M, Morillo C, Terricabras M, Amit G, Roux JF, Patterson S, Verma A. Relationship between quality of life and burden of recurrent atrial fibrillation following ablation: CAPCOST multicentre cohort study. Europace. 2020 Jul 1;22(7):1017-1025. doi: 10.1093/europace/euaa066.
PubMed 32531030
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective, Multicenter Canadian Atrial Fibrillation PVAC Cohort Study
- ClinicalTrials.gov ID
- NCT01562912
- Acronym / sponsor ID
- CAPCOST / NERG-01
- Conditions
- Atrial Fibrillation
- Keywords
- radiofrequency, ablation, atrial fibrillation, PVAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Newmarket Electrophysiology Research Group IncUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Feb 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 26 Mar 2012 (estimated)
- 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.
Atrial fibrillation (AF) is the most common arrhythmia affecting the Canadian population. AF is associated with increased risk of stroke,HF, and even mortality. AF can cause debilitating symptoms, adversely affect patient's (pt's) quality of life and functional status. Hence a strategy of sinus rhythm (SR) may be pursued over a strategy of allowing AF to persist. Percutaneous catheter ablation is an effective alternative to antiarrhythmic drugs (AAD) for maintaining SR. The success rate of PV isolation off AAD is about 80-90% in pt's with PAF, but repeat procedures are required in up to 40% of pt's. After one ablation, the success rate may only be 50-70% off drugs.Current standard ablation procedures for PV antral isolation employ mapping systems which reconstructions of the LA and PV anatomy are created. Visualization may be supplemented by integration of CT/ MRI images and/or intracardiac echocardiography. Robotic navigation has been employed to assist in ablation. Based on single point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point around the PVs to obtain electrical isolation.This results in lengthy complex, costly procedures,often more than 4 hours, which requires high degree of operator skill.Creation of contiguous, transmural lesions is challenging with standard single-point RF. A novel multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC catheter, Medtronic Inc.) An over-the-wire circular mapping/ablation catheter can be advanced into the PV antrum, and multiple lesions around the circumference of the catheter can be delivered simultaneously using duty-cycled unipolar and bipolar RF energy. Early reports, the system can achieve complete PV isolation with reduced fluoroscopy and procedural times using lower powers to achieve more reliable lesion sets.Long-term efficacy also seems comparable to standard RF ablation.This novel technology has potential to broaden the application of AF ablation, making procedures less time-consuming, less complex without compromising procedural efficacy. Published data PVAC technology outcomes are limited to studies with small sample sizes of 12-102 pt's. Data has been restricted to a small number of European centers performing moderate numbers of PVAC procedures. There is no prospective, multicenter data. Little is known about the efficiency of PVAC procedures, allowing for an assessment of cost-effectiveness in using this technology.
Detailed description
This is a multicenter, open label, prospective, cohort study. Patients undergoing ablation with PVAC technology in up to 15 centers across Canada will be enrolled, ablated, and followed for one year post-ablation. Both primary and secondary objectives of the study will be determined from this cohort of patients. Comparisons to the traditional ablation methods will be made by collecting data from a prospective group of control subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. While the final ratio of control to PVAC patients must be 1:2 by study end for each operator, the ratio may vary while the study is conducted to allow some flexibility in patient recruitment. However, the absolute difference between [# of PVAC patients] and 2x[# control patients] should not exceed 5 at any given time for any operator in any study center
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Radiofrequency Ablation ProcedureRadiofrequency Ablation Procedure. Subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. Intervention is the use of Radiofrequency Ablation. |
| PVAC Ablation Procedure | Experimental | Device: PVAC Ablation ProcedureIntervention is the use of PVAC technology. The PVAC is deployed in the left atrium over a 0.032-inch guidewire inside the PV and advanced until it is wedged within the antrum proximal to the ostium. Energy is delivered through selected electrode pairs with local potentials as well as adjacent electrode pairs, allowing bipolar current to flow to the target electrode(s) from both sides. Each application lasts for 60 seconds. When the temperature does not rise above 50°C within 15 seconds, the application should be discontinued to improve position. The PVAC may be manipulated within the antrum to ablate in a pattern of overlapping circular lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years or greater.
- Patients undergoing first-time catheter ablation for AF.
- Patients with paroxysmal AF. Paroxysmal AF will be defined as self-terminating episodes less than 7 days duration. Patients should have had at least 3 episodes of AF in a one year period.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of enrollment in the study.
Key exclusion criteria (6 listed)
- Patients with persistent AF (defined as an episode of AF lasting >7 days).
- Patients with AF felt to be secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor.
- Patients who have previously undergone AF ablation.
- Patients with left atrial size >/= 55 mm (2D echocardiography, parasternal long axis view).
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 |
|---|---|---|
| Radiofrequency Ablation ProcedureAlso: THERMOCOOL Catheter, Biosense Webster, EnSite NavX Velocity, St Jude, LASSO Circular Mapping Catheter, Biosense WebsterApplication of radiofrequency energy will be delivered during PV antral isolation procedure and should be performed with a standard, open irrigated ablation catheter and a mapping system as the investigator would perform the procedure normally. | Device | Control |
| PVAC Ablation ProcedureAlso: PVAC Catheter, Medtronic Inc., Ablation FrontiersApplication of radiofrequency energy with the Pulmonary Vein Ablation Catheter(PVAC)to eliminate potentials arising from the pulmonary veins. | Device | PVAC Ablation Procedure |
Primary outcome
Procedure Duration and Fluoroscopy time
Time frame: At the time of the initial ablation procedure and repeat ablations.
Length of procedure measure in hours/minutes and use of fluoroscopy measured in minutes
3 secondary outcomes
Incidence of emergency room visits, hospitalizations and urgent clinic visits.
Time frame: 1 year follow-up post ablation
Quality of Life measurements (CCS-SAF, AFEQT and SF-12)
Time frame: 1 year post ablation
Total ablation procedure costs.
Time frame: 1 year post ablation
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 29 Mar 2018.
- Derived from this study: PubMed 32531030Essebag V, Azizi Z, Alipour P, Khaykin Y, Leong-Sit P, Sarrazin JF, Sturmer M, Morillo C, Terricabras M, Amit G, Roux JF, Patterson S, Verma A. Relationship between quality of life and burden of recurrent atrial fibrillation following ablation: CAPCOST multicentre cohort study. Europace. 2020 Jul 1;22(7):1017-1025. doi: 10.1093/europace/euaa066.
- Individual participant dataSharing planned: Undecided. to be determined
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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.
Atul Verma, MD principal investigator
Newmarket Electrophysiology Research Group
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation Procedure and PVAC Ablation Procedure in people with Atrial Fibrillation, run by Newmarket Electrophysiology Research Group Inc 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 6 inclusion and 6 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 29 Mar 2018. 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?
Procedure Duration and Fluoroscopy time (time frame: At the time of the initial ablation procedure and repeat ablations.). 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 NCT01562912, 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 29 Mar 2018.