Atrial Fibrillation study: Pace and Ablate vs Medication
Official title RAFT - Pace &Ablate
ClinicalTrials.gov ID: NCT06299514
What this study is testing
What is Medication?
Medication is an investigational medicine, being studied as a potential treatment for atrial fibrillation.
Also referred to as Optimal heart failure therapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if conduction system pacing combined with AV‑node ablation works better than the best drug treatment for controlling irregular heartbeats.
- Who it's for
- Adults who have atrial fibrillation and need better heart‑rate control, especially if medicines cause side effects.
- What's involved
- Participants will be assigned to either receive a special pacemaker placed using a newer pacing technique plus a small procedure to block the AV node, or to continue their usual medication regimen, with regular check‑ups and heart tests.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with permanent AF/persistent AF (in AF)
- Patients with NYHA Class II -IVa HF symptoms
- for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L
- for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
You likely can't join if
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
See the full eligibility criteria
- Patients with permanent AF/persistent AF (in AF)
- Patients with NYHA Class II -IVa HF symptoms
- for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L
- for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
- In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome \<4 weeks or coronary revascularization \<3months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
- Severe pulmonary diseases requiring oxygenation
- Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies...
- Patients enrolled in competitive clinical trials that will affect the objectives of this study
- Existing CRT/BiVP
- Patients who are pregnant
- Guideline indication for CRT
- More than 20% pacing with an existing pacemaker
- Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)
The study team makes the final eligibility decision.
Where it is enrolling
- Victoria, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kitchener, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Victoria, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kitchener, Ontario, Canada; London, Ontario, Canada; Newmarket, Ontario, Canada and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.