Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation (NAFAPAF)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Eastbourne General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Eastbourne General Hospital
Information provided by:
Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01057485
First received: January 26, 2010
Last updated: May 25, 2010
Last verified: January 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 26, 2010 | ||||
| Last Updated Date | May 25, 2010 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01057485 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation | ||||
| Official Title ICMJE | Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation | ||||
| Brief Summary | The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Persistent Atrial Fibrillation | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01057485 | ||||
| Other Study ID Numbers ICMJE | NAFAPAFv1.3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr AN Sulke, NHS | ||||
| Study Sponsor ICMJE | Eastbourne General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Eastbourne General Hospital | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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