Efficiency Study Evaluating the Use of PVAC Catheter Technology for Performing Ablation in Pts With Atrial Fibrillation (CAPCOST)

• ClinicalTrials.gov Identifier: NCT01562912
• Recruitment Status: Completed
• First Posted: March 26, 2012
• Last Update Posted: March 29, 2018
• Sponsor: Newmarket Electrophysiology Research Group Inc
• Collaborator: Medtronic
• Information provided by (Responsible Party): Newmarket Electrophysiology Research Group Inc

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Radiofrequency Ablation Procedure; Device: PVAC Ablation Procedure	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 230 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Prospective, Multicenter Canadian Atrial Fibrillation PVAC Cohort Study
• Study Start Date: February 2012
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: March 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; 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.	Device: Radiofrequency Ablation Procedure; 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.; Other Names: THERMOCOOL Catheter, Biosense Webster; EnSite NavX Velocity, St Jude; LASSO Circular Mapping Catheter, Biosense Webster
Experimental: PVAC Ablation Procedure; 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.	Device: PVAC Ablation Procedure; Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter(PVAC)to eliminate potentials arising from the pulmonary veins.; Other Name: PVAC Catheter, Medtronic Inc., Ablation Frontiers

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Incidence of emergency room visits, hospitalizations and urgent clinic visits. [ Time Frame: 1 year follow-up post ablation ]
   Incidence of emergency room visits, hospitalizations and urgent clinic visits one year prior to ablation and 3, 6, 9, and 12 months post ablation.
2. Quality of Life measurements (CCS-SAF, AFEQT and SF-12) [ Time Frame: 1 year post ablation ]
   Quality of Life measurements (CCS-SAF , AFEQT and SF-12) questionnaires at baseline, 3, 6 , 9 and 12 months.
3. Total ablation procedure costs. [ Time Frame: 1 year post ablation ]
   calculation of procedural costs

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Canada, Ontario

Hamilton Health Sciences

Hamilton, Ontario, Canada

London Health Sciences Center

London, Ontario, Canada, N6A 5A5

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 2P9

Canada, Quebec

McGill University Health Centre

Montreal, Quebec, Canada, H3G 1A4

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada, H4J 1C5

Institut universitaire de cardiologie et de pneumologie de Québec

Quebec City, Quebec, Canada, G1V 4G5

Sponsors and Collaborators

Newmarket Electrophysiology Research Group Inc

Medtronic

Investigators

• Principal Investigator: Atul Verma, MD; Newmarket Electrophysiology Research Group

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Newmarket Electrophysiology Research Group Inc
• ClinicalTrials.gov Identifier: NCT01562912
• Other Study ID Numbers: NERG-01
• First Posted: March 26, 2012
• Last Update Posted: March 29, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: to be determined

Keywords provided by Newmarket Electrophysiology Research Group Inc:

radiofrequency; ablation; atrial fibrillation; PVAC

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes