Ablation for Atrial Fibrillation

Hospital of the University of Pennsylvania, Philadelphia, PA
Atrial FibrillationAblation - Procedure
Eligibility
18+
All Sexes

Study Summary

This trial will compare the effectiveness of three different methods for treating atrial fibrillation by looking at how well patients do after having the procedure a second time.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Spironolactone
2
Antiarrhythmic Medications
3
Phase 2 Empiric Heart Failure Therapy

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Primary efficacy endpoint
Secondary endpoint

Trial Safety

Phase-Based Safety

1 of 3

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1
Spironolactone
3
Antiarrhythmic Medications
3
Phase 2 Empiric Heart Failure Therapy

Side Effects for

MVS + Ablation
19%Cardiac conduction abnormalities requiring PPM
14%Arrhythmias-Sustained supraventricular arrhythmia
11%Heart Failure
8%Pleural Effusion
6%Major Infection - Localized - Other
6%Major Infection - Sepsis
5%Bleeding
5%Respiratory Failure
3%Renal Failure (dialysis)
3%Pericardial Fluid Collection
3%Arrhythmias-Sustained ventricular arrhythmia
3%Pneumothorax
2%Neurological Dysfunction - CVA-Ischemic
2%Major Infection - Localized - Pneumonia
2%Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
2%Neurological Dysfunction - Toxic Metabolic Encephalopathy
2%Venous Thromboembolism Event
2%Renal Dysfunction (no dialysis)
2%Myocardial Infarction
2%Hepatic Dysfunction
1%Neurological Dysfunction - CVA-Hemorrhagic
1%Major Infection - Endocarditis
1%Non-infectious Pericarditis
1%Right Heart Failure
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT00903370) in the MVS + Ablation ARM group. Side effects include: Cardiac conduction abnormalities requiring PPM with 19%, Arrhythmias-Sustained supraventricular arrhythmia with 14%, Heart Failure with 11%, Pleural Effusion with 8%, Major Infection - Localized - Other with 6%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Posterior wall isolation
1 of 3
CTI/AAD (control)
1 of 3
Empiric Isolation of common trigger sites
1 of 3

Experimental Treatment

147 Total Participants · 3 Treatment Groups

Primary Treatment: Ablation · No Placebo Group · N/A

Posterior wall isolation
Procedure
Experimental Group · 1 Intervention: Ablation · Intervention Types: Procedure
CTI/AAD (control)
Procedure
Experimental Group · 1 Intervention: Ablation · Intervention Types: Procedure
Empiric Isolation of common trigger sites
Procedure
Experimental Group · 1 Intervention: Ablation · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ablation
2010
Completed Phase 4
~1340

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,899 Previous Clinical Trials
41,217,946 Total Patients Enrolled
16 Trials studying Atrial Fibrillation
2,823 Patients Enrolled for Atrial Fibrillation
David Lin, MDPrincipal InvestigatorUniversity of Pennsylvania
Sanjay Dixit, MDPrincipal InvestigatorUniversity of Pennsylvania
5 Previous Clinical Trials
566 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
566 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the cumulative scope of participants in this medical research?

"Affirmative. According to information posted on clinicaltrials.gov, this experiment is ongoing with its commencement recorded as December 13th 2021 and the most recent update being January 10th 2022. A total of 147 participants are anticipated for recruitment at one location." - Anonymous Online Contributor

Unverified Answer

Is there currently an initiative to enroll participants in this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that this medical trial is still actively searching for participants, having first been posted in December 13th 2021 and updated as recently as January 10th 2022. The study seeks to recruit 147 individuals from a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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