Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation

Atrial Fibrillation Clinical Trial

— Alster-Lost  

Official title:

Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820625
• Other study ID #: 1787
• Secondary ID: PV 2961
• Status: Completed
• Phase: N/A
• First received: January 9, 2009
• Last updated: February 6, 2017
• Start date: May 2008
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Asklepios proresearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• long standing persistent atrial fibrillation > 6 months and < 5 years

Exclusion Criteria:

• renal failure

• left atrial size >55 mm

Related Conditions & MeSH terms

• Atrial Fibrillation
• Tachycardia

Intervention

Procedure:
• pulmonary vein isolation
common pulmonary vein isolation procedure
• pulmonary vein isolation with additional ablation of fragmented potentials
common pulmonary vein isolation with additional but also common ablation of fragmented potentials

Locations

Country	Name	City	State
Germany	Asklepios Klinik St. Georg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Asklepios proresearch

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	data collection in view of acute and chronic success rate		12 months
Secondary	data collection of complications in both groups and also procedure parameters		12 months