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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Newmarket Electrophysiology Research Group Inc
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov Identifier:
NCT01562912
First received: February 20, 2012
Last updated: September 23, 2014
Last verified: September 2014

February 20, 2012
September 23, 2014
February 2012
October 2015   (final data collection date for primary outcome measure)
Procedure Duration and Fluoroscopy time [ Time Frame: At the time of the initial ablation procedure and repeat ablations. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562912 on ClinicalTrials.gov Archive Site
  • Incidence of emergency room visits, hospitalizations and urgent clinic visits. [ Time Frame: 1 year follow-up post ablation ] [ Designated as safety issue: No ]
    Incidence of emergency room visits, hospitalizations and urgent clinic visits one year prior to ablation and 3, 6, 9, and 12 months post ablation.
  • Quality of Life measurements (CCS-SAF, AFEQT and SF-12) [ Time Frame: 1 year post ablation ] [ Designated as safety issue: No ]
    Quality of Life measurements (CCS-SAF , AFEQT and SF-12) questionnaires at baseline, 3, 6 , 9 and 12 months.
  • Total ablation procedure costs. [ Time Frame: 1 year post ablation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficiency Study Evaluating the Use of the PVAC Catheter Technology for Performing Ablation in Patients With Atrial Fibrillation
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, heart failure, and even mortality1. AF can also cause debilitating symptoms and adversely affect a patient's quality of life and functional status. These are amongst several reasons why a strategy of sinus rhythm may be pursued over a strategy of allowing AF to persist2-6.

Percutaneous catheter ablation has emerged as an effective alternative to antiarrhythmic drugs (AAD) for maintaining sinus rhythm7. The cornerstone of AF ablation procedures today is electrical disconnection or "isolation" of the pulmonary vein (PV) antra from the rest of the left atrium (LA)8-13. In experienced hands, the success rate of PV isolation off AAD is about 80-90% in patients with paroxysmal AF, but repeat procedures are required in up to 40% of patients14-18. Thus, after one ablation, the success rate may only be 50-70% off drugs.

Current standard ablation procedures for PV antral isolation employ mapping systems with which reconstructions of the LA and PV anatomy can be created. Visualization may be supplemented by integration of CT or MRI images and/or intracardiac echocardiography. Robotic navigation systems have also been employed to assist in ablation. The result is that ablation technology has become very complex and costly. Furthermore, all of these technologies are based on a single point unipolar radiofrequency (RF) ablation catheter where lesions are created point-by-point around the PVs to eventually obtain electrical isolation. This results in a lengthy procedure, often more than 4 hours, which requires a high degree of operator skill. Creation of contiguous, transmural lesions is also challenging with standard single-point RF.

Recently, a novel multipolar catheter ablation system has been evaluated for achieving PV isolation (PVAC catheter, Ablation Frontiers, Medtronic Inc., Minneapolis, MN). Based on an over-the-wire circular mapping and ablation design, the 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. In early reports, the system can achieve complete PV isolation with reduced fluoroscopy and procedural times and uses lower powers to achieve more reliable lesion sets19-21. Long-term efficacy also seems comparable to standard RF ablation22,23.

This novel technology has the potential to broaden the application of AF ablation, by making the procedures less time-consuming and less complex without compromising on procedural efficacy. However, published data on outcomes related to use of PVAC technology are limited to studies with relatively small sample sizes ranging from 12 to 102 patients20-25. Data has been restricted to experiences from a small number of European centers performing moderate numbers of PVAC procedures and there is no prospective, multicenter data. The investigators therefore know little about the efficiency of PVAC procedures, which in turn, may allow for an assessment of the cost-effectiveness of using this technology.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • 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
  • Device: Radiofrequency 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
  • Active Comparator: 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.
    Intervention: Device: Radiofrequency Ablation Procedure
  • Experimental: PVAC Cohort
    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.
    Intervention: Device: Radiofrequency Ablation Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2016
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Atul Verma, MD 905-953-7917 atul.verma@utoronto.ca
Contact: Vidal Essebag, MD
Canada
 
NCT01562912
NERG-01
No
Newmarket Electrophysiology Research Group Inc
Newmarket Electrophysiology Research Group Inc
Medtronic
Principal Investigator: Atul Verma, MD Newmarket Electrophysiology Research Group
Newmarket Electrophysiology Research Group Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP