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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03044925
Other study ID # 20161404
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2016
Est. completion date December 31, 2020

Study information

Verified date September 2019
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.


Description:

1. Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

2. Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

3. Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

4. Compare the effects of amiodarone on recurrence after these two different ablation procedures.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Persistent atrial fibrillation (>7d, < 5years)

2. Age 18-75 years

3. Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol

Exclusion Criteria:

1. Any previous left atrial ablation or surgery

2. Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment

3. Stroke or transient ischemic attack within 6 months prior to enrollment

4. Myocardial infarction within 3 months prior to enrollment

5. Anteroposterior left atrial diameter > 55 mm

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote magnetic navigation
Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
Cryoablation
Pulmonary vein isolation and other areas ablation used by cryoballoon

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

References & Publications (4)

Jin QI, Pehrson S, Jacobsen PK, Chen XU. Efficacy and Safety of Atrial Fibrillation Ablation Using Remote Magnetic Navigation: Experience from 1,006 Procedures. J Cardiovasc Electrophysiol. 2016 Mar;27 Suppl 1:S23-8. doi: 10.1111/jce.12929. — View Citation

Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9 — View Citation

Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal a — View Citation

Kuniss M, Greiß H, Pajitnev D, Akkaya E, Deubner N, Hain A, Bodammer L, Berkowitsch A, Chierchia GB, Hamm CW, Neumann T. Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduct — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical efficacy (time to first AF recurrence after blanking period) the time to first AF recurrence after blanking period (month) one year
Primary Clinical safety (Any procedure-related complications) Any procedure-related complications one year
Secondary Procedure time (min) one week
Secondary Time to first cardiovascular hospitalization (month) one year
Secondary QoL of 12 months (Units on a Scale) one year
Secondary X-ray time (min) one week
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