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

This study is ongoing, but not recruiting participants.
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 14, 2017
Last verified: September 2017
  Purpose
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 Intervention
Atrial Fibrillation Device: Radiofrequency Ablation Procedure Device: PVAC Ablation Procedure

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Newmarket Electrophysiology Research Group Inc:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • Total ablation procedure costs. [ Time Frame: 1 year post ablation ]
    calculation of procedural costs


Enrollment: 230
Study Start Date: February 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562912

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

Responsible Party: Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov Identifier: NCT01562912     History of Changes
Other Study ID Numbers: NERG-01
Study First Received: February 20, 2012
Last Updated: September 14, 2017
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

ClinicalTrials.gov processed this record on September 21, 2017