Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01703247
Other study ID # GP-LL-AF
Secondary ID
Status Completed
Phase Phase 2
First received October 5, 2012
Last updated October 9, 2012
Start date January 2008
Est. completion date May 2009

Study information

Verified date October 2012
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years with the use of an implanted monitoring device (IMD).


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date May 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Persistent and longstanding persistent AF

Exclusion Criteria:

- congestive heart failure

- LV ejection fraction < 35%

- left atrial diameter > 60 mm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Pulmonary vein isolation

Ganglionated plexi ablation

Linear Lesion Ablation


Locations

Country Name City State
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk

Sponsors (1)

Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia 3 years Yes
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT03650556 - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation N/A
Recruiting NCT04085731 - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn NCT02344394 - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation N/A
Completed NCT01694563 - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation N/A
Terminated NCT01683045 - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats N/A
Active, not recruiting NCT03643224 - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation N/A
Withdrawn NCT05093868 - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF) N/A
Completed NCT05152966 - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II) N/A
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting NCT06124690 - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Not yet recruiting NCT05454111 - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation N/A
Active, not recruiting NCT05077670 - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn NCT03835338 - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm N/A
Completed NCT02275104 - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy N/A
Not yet recruiting NCT05565183 - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation. N/A
Completed NCT02274857 - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures N/A