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Procedure

P&A-BiVP for Heart Failure

N/A
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

"This trial aims to compare the effectiveness of two different pacemaker techniques, BiVP and CSP, in patients with atrial fibrillation. These techniques are used in patients who undergo a procedure called AV node

Who is the study for?
This trial is for older adults with atrial fibrillation, a type of irregular heartbeat that can cause symptoms like skipped beats or shortness of breath. It's specifically for those who struggle to tolerate standard medications due to side effects and may benefit from a pacemaker combined with AV node ablation.Check my eligibility
What is being tested?
The study compares two types of pacemakers: BiVP, which stimulates both sides of the heart, and CSP, a newer method with fewer leads. It also tests if these 'pace and ablate' strategies are better than just using drugs to manage heart rate in patients with AF.See study design
What are the potential side effects?
Potential side effects include complications from implanting the pacemaker such as infection or bleeding, issues arising from damaging the AV node like abnormal heart rhythms, and typical medication-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Winratio
Secondary outcome measures
All-cause hospitalization
All-cause mortality
Biochemical marker
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: P&A-CSPExperimental Treatment1 Intervention
Patients randomized to P&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.
Group II: P&A-BiVPExperimental Treatment1 Intervention
Patients randomized to P&A-BiVP will receive a cardiac resynchronization therapy (CRT) pulse generator, and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.
Group III: Pharmacological TherapyActive Control1 Intervention
Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
658 Previous Clinical Trials
412,458 Total Patients Enrolled
8 Trials studying Heart Failure
832 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial currently accepting new participants?

"According to clinicaltrials.gov, recruitment for this particular trial has concluded. The initial posting was made on March 10th, 2024, with the most recent update occurring on March 1st of the same year. Despite closure of enrollment in this study, there are currently a significant number of 1220 other trials actively seeking participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
RAFT-P&A Randomized Control Trial
2024. "RAFT-P&A Randomized Control Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299514.
~800 spots leftby Dec 2028
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