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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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