Atrial Fibrillation Clinical Trial
— RACE-AFOfficial title:
Radiofrequency vs Cryoballoon Catheter Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation - Effect on Atrial Fibrillation Burden Assessed by Implantable Cardiac Monitor (RACE-AF Trial)
NCT number | NCT03805555 |
Other study ID # | H-2-2014-013 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | October 2020 |
Verified date | September 2021 |
Source | University Hospital, Gentofte, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein isolation. Primary endpoint for the randomized comparison is the number of pulmonary veins that remain isolated on follow up investigation. All patients will receive an implantable loop recorder to monitor clinical response and identify patients who benefit the most from durable pulmonary vein isolation. All patients will undergo a follow-up invasive assessment of pulmonary vein isolation, and veins with reconnection will be re-isolated to determine if this strategy alters clinical long-term outcome of ablation.
Status | Completed |
Enrollment | 105 |
Est. completion date | October 2020 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Paroxysmal atrial fibrillation - >2 episodes in 3 months prior to enrollment - Clinical indication for ablation Exclusion Criteria: - Contraindication for ablation - Valvular heart disease - Persistent AF only (>7 days duration or <7 days duration but requiring cardioversion, as persistent AF was customarily defined at the beginning of this study) - Documented atrial flutter or other arrhythmias requiring other ablation than PVI - Implanted pacemaker or defibrillator - Pregnancy - Malignant disease (non metastatic skin cancer excluded) - Obesity (BMI >35) - Uncontrolled hypertension (BT > 160/100 mmHg on repeated measurements) - Severe sleep apnea - Active systemic infection - Renal insufficiency with S-creatinin > 150 micromol/l - Psychiatric illness or substance abuse - Participation in other clinical studies involving medical treatment |
Country | Name | City | State |
---|---|---|---|
Denmark | Gentofte Hospital | Hellerup |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
Andrade JG, Khairy P, Guerra PG, Deyell MW, Rivard L, Macle L, Thibault B, Talajic M, Roy D, Dubuc M. Efficacy and safety of cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. 2011 Sep;8(9):1444-51. doi: 10.1016/j.hrthm.2011.03.050. Epub 2011 Mar 30. Review. Erratum in: Heart Rhythm. 2011 Nov;8(11):1828. — View Citation
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. — View Citation
Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y, Martin A, Williams CJ, Sledge I. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):349-61. doi: 10.1161/CIRCEP.108.824789. Epub 2009 Jun 2. Review. — View Citation
Cosedis Nielsen J, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS. Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012 Oct 25;367(17):1587-95. doi: 10.1056/NEJMoa1113566. — View Citation
Di Biase L, Wang Y, Horton R, Gallinghouse GJ, Mohanty P, Sanchez J, Patel D, Dare M, Canby R, Price LD, Zagrodzky JD, Bailey S, Burkhardt JD, Natale A. Ablation of atrial fibrillation utilizing robotic catheter navigation in comparison to manual navigation and ablation: single-center experience. J Cardiovasc Electrophysiol. 2009 Dec;20(12):1328-35. doi: 10.1111/j.1540-8167.2009.01570.x. — View Citation
Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, Sullivan T, Roberts-Thomson KC, Sanders P. Long-term outcomes of catheter ablation of atrial fibrillation: a systematic review and meta-analysis. J Am Heart Assoc. 2013 Mar 18;2(2):e004549. doi: 10.1161/JAHA.112.004549. Review. — View Citation
Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Pürerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):141-7. doi: 10.1161/CIRCEP.109.877852. Epub 2010 Feb 16. — View Citation
Jons C, Hansen PS, Johannessen A, Hindricks G, Raatikainen P, Kongstad O, Walfridsson H, Pehrson S, Almroth H, Hartikainen J, Petersen AK, Mortensen LS, Nielsen JC; MANTRA-PAF Investigators. The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial: clinical rationale, study design, and implementation. Europace. 2009 Jul;11(7):917-23. doi: 10.1093/europace/eup122. Epub 2009 May 15. — View Citation
Karasoy D, Gislason GH, Hansen J, Olesen JB, Torp-Pedersen C, Johannessen A, Hansen ML. Temporal changes in patient characteristics and prior pharmacotherapy in patients undergoing radiofrequency ablation of atrial fibrillation: a Danish nationwide cohort study. Europace. 2013 May;15(5):669-75. doi: 10.1093/europace/eus418. Epub 2013 Jan 2. — View Citation
Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. 2010 Sep;96(17):1379-84. doi: 10.1136/hrt.2009.192419. — View Citation
Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaïs P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reduction in AF-burden | Reduction (%) in AF-burden (i.e. the percentage of a given time that the patients is in AF) assessed by continuous heart rhythm monitoring using implantable cardiac monitor before the index procedure vs. after the 1st blanking period and before follow-up invasive assessment vs. after the 2nd blanking period | 2 years | |
Primary | Number of veins with durable isolation assessed by invasive follow-up 4-6 months after the index procedure. | For all patients: at the earliest 4 months and the latest 6 months after the initial pulmonary vein isolation, follow-up invasive assessment of bidirectional (entrance and exit) block to all pulmonary veins are performed using 3D computer mapping, and the number of veins without electrical reconnection (i.e. with durable isolation) are carefully recorded. | 4-6 months | |
Secondary | Treatment failure constituted by the recurrence of atrial fibrillation (AF) after the blanking period (i.e. after the first 3 months following the index procedure). | Treatment failure constituted by the recurrence of AF is defined as: > 1 symptomatic AF-episode > 5 minutes, assessed by patient interview at the follow-up visits and continuous invasive heart rhythm monitoring using implantable cardiac monitor (ICM) Any episode requiring cardioversion assessed by patient interview at the follow-up visits, hospital records and data from the patients ICM. New onset treatment with antiarrhythmic drug (class 1C antiarrhythmic drugs, dronedarone or amiodarone) assessed by patient interview at the follow up visits and hospital records. < 90% reduction in AF-burden (prior to the initial pulmonary vein isolation vs. after the 3 month blanking period but prior to the follow-up invasive assessment) |
4-6 months | |
Secondary | Number of patients where procedural endpoint is met: all pulmonary veins isolated and observed isolated for 20 minutes. | At the end of pulmonary vein isolation ablation achievement of procedural endpoint is recorded. Procedural endpoint is defined as bidirectional block to all pulmonary veins after a waiting period of no less than 20 minutes after the last ablation application. | During index procedure | |
Secondary | Duration of the index procedure | The duration (in minutes) of the index procedure is considered to start at the time of local anesthetic administration and to end at the time of catheter extraction. | During index procedure | |
Secondary | X-ray exposure from the index procedure | X-ray exposure (in cGy·cm^2) during the index procedure is quantified as the absorbed dose of radiation multiplied by the area irradiated. | During index procedure | |
Secondary | Number of patients with procedure related complications. | During the procedure and through patient interviews at the follow-up visits any procedure related complications are carefully recorded. | 0-3 months | |
Secondary | Number of patients with all veins isolated at follow-up invasive assessment. | For all patients: at the earliest 4 months and at the latest 6 months after the initial pulmonary vein isolation, follow-up invasive assessment of bidirectional (entrance and exit) block to all pulmonary veins are performed using 3D computer mapping. | 4-6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |